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Wang Z, Zhan R, Mo L, Zhang J, Hu J, Tan S, He Q, Li P, Sun W, Wang X, Jiang J, Liu L, Zhang Y, Bai Y. Comparison of effect of remimazolam and propofol on respiration of patients under deep sedation for colonoscopy: a prospective multicenter randomized controlled trial. Eur J Med Res 2025; 30:250. [PMID: 40189570 PMCID: PMC11974117 DOI: 10.1186/s40001-025-02519-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/20/2023] [Accepted: 03/26/2025] [Indexed: 04/09/2025] Open
Abstract
BACKGROUND Remimazolam recently became available as a sedative. The comparison of the respiratory suppression effects of remimazolam and propofol under deep sedation for colonoscopy was not thoroughly unclear, particularly with regard to the novel metric of time to first airway intervention. The goal of this study was to systemically compare the respiration profiles of the patients sedated with remimazolam and propofol at the comparable sedation level in the patients undergoing colonoscopy. METHODS Four hundred-fifty outpatients were randomly assigned to remimazolam (Group Rem, n = 225) and propofol (Group Pro, n = 225). The target sedation level was the modified Observer's Assessment of Alertness/Sedation ≤ 2. The primary outcome was elapsed time from anesthesia induction to first airway intervention. Secondary outcomes included incidence and severity of hypoxia and apnea, minute ventilation (MV), tidal volume (TV), and respiratory rate (RR). RESULTS The elapsed time from induction to the first airway intervention was 11 ± 8 min in Group Rem (n = 208) vs. 5 ± 6 min in Group Pro (n = 208, P < 0.001). Patients in Group Rem required less frequent airway intervention and had a lower incidence of and shorter duration of apnea than patients in Group Pro (all P < 0.001). MV at 1 min, 2 min, 4 min post-induction, and at the end of the procedure were higher in Group Rem than those in Group Pro (P < 0.001). CONCLUSIONS Patients sedated with remimazolam vs. propofol during colonoscopy maintain improved respiration and require less frequent airway intervention, and have lower incidence of adverse events. Clinical trial registration and registry URL ChiCTR2000034527, registered at www.chictr.org.cn.
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Affiliation(s)
- Zhengjia Wang
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
| | - Renshu Zhan
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
| | - Liqun Mo
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
- Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China
| | - Jin Zhang
- Department of Pharmacology and Toxicology, University of Mississippi Medical Center, Jackson, MS, USA
| | - Jie Hu
- Department of Anesthesiology, Xuyong County People's Hospital, Xuyong, China
| | - Shoupeng Tan
- Department of Anesthesiology, The Second People's Hospital of Guangyuan, Guangyuan, China
| | - Qiongzhen He
- Department of Anesthesiology, Guangyuan Mental Health Center, Guangyuan, China
| | - Ping Li
- Department of Anesthesiology, The People's Hospital of Yuechi, Yuechi, China
| | - Wekong Sun
- Department of Anesthesiology, Cangxi People's Hospital, Cangxi, China
| | - Xiaobin Wang
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
- Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China
| | - Jun Jiang
- Department of General Surgery (Thyroid Surgery), The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Li Liu
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
- Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China
| | - Yingying Zhang
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China
- Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China
| | - Yiping Bai
- Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China.
- Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China.
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Liu X, Shui G, Wang Y, Chen T, Zhang P, Liu L, Li C, Li T, Wang X. Remimazolam alleviates myocardial ischemia/reperfusion injury and inflammation via inhibition of the NLRP3/IL‑1β pathway in mice. Int J Mol Med 2025; 55:57. [PMID: 39886966 DOI: 10.3892/ijmm.2025.5498] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2024] [Accepted: 11/25/2024] [Indexed: 02/01/2025] Open
Abstract
Remimazolam (Rema) is a novel anesthetic that is widely used in anesthesia and sedation in critically ill patients. Notably, Rema exerts effects in patients through activation of the γ‑aminobutyric acid (GABA) receptor. GABA may alleviate myocardial ischemia/reperfusion (I/R) injury; however, the impact of Rema and underlying molecular mechanism in myocardial I/R injury remain to be fully understood. Therefore, the present study aimed to investigate the effects of Rema on cardiac I/R injury and to determine the underlying mechanisms. An acute myocardial I/R model was established by ligating the left anterior descending artery in adult male C57BL/6 mice (8‑10 weeks). Cultured Raw264.7 cells treated with lipopolysaccharide (LPS) were also used to investigate the effect of Rema on macrophages. The results of the present study revealed that Rema improved I/R‑induced cardiac dysfunction by increasing the ejection fraction value and reducing the myocardial infarction area. In addition, Rema also alleviated I/R‑induced cardiac inflammatory cell infiltration based on H&E and immunofluorescence staining. Transmission electron microscopy and ROS measurements showed that Rema improved I/R‑induced mitochondrial structural disruption and oxidative stress in cardiomyocytes. Transcriptomics analysis and reverse transcription‑quantitative PCR revealed that Rema alleviated I/R‑induced release of inflammatory factors and cytokines by inhibiting the expression of IL‑1β, IL‑6, C‑C chemokine receptor 2 and C‑X‑C motif chemokine ligand 5. Rema also inhibited I/R‑induced CD68+ cell proliferation, IL‑1β release, and NOD‑like receptor thermal protein domain associated protein 3 (NLRP3) and IL‑1β expression. The results of in vitro assays revealed that Rema inhibited LPS‑induced increases in IL‑1β, IL‑6 and TNF‑α expression and release in cultured RAW264.7 macrophages. In conclusion, the present study revealed that Rema may alleviate I/R‑induced cardiac dysfunction and myocardial injury by inhibiting oxidative stress and inflammatory responses via the NLRP3/IL‑1β pathway.
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Affiliation(s)
- Xueru Liu
- Department of Anesthesiology, Affiliated Hospital, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Guojing Shui
- Department of Anesthesiology, Affiliated Hospital, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Yan Wang
- Key Laboratory of Medical Electrophysiology of the Ministry of Education, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Tangting Chen
- Key Laboratory of Medical Electrophysiology of the Ministry of Education, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Peng Zhang
- Key Laboratory of Medical Electrophysiology of the Ministry of Education, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Li Liu
- Department of Anesthesiology, Affiliated Hospital, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Chunhong Li
- Department of Pharmaceutical Sciences, School of Pharmacy, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Tao Li
- Key Laboratory of Medical Electrophysiology of the Ministry of Education, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
| | - Xiaobin Wang
- Department of Anesthesiology, Affiliated Hospital, Southwest Medical University, Luzhou, Sichuan 646000, P.R. China
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Egan TC, Abbott TEF, Ackland GL. Handheld ultrasound versus palpation technique for radial artery cannulation in conscious patients before noncardiac surgery: an open-label randomised controlled study. Br J Anaesth 2025; 134:1208-1210. [PMID: 39922787 PMCID: PMC11947581 DOI: 10.1016/j.bja.2025.01.016] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/10/2024] [Revised: 12/27/2024] [Accepted: 01/18/2025] [Indexed: 02/10/2025] Open
Affiliation(s)
- Timothy C Egan
- Department of Anaesthesia and Perioperative Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK
| | - Tom E F Abbott
- Department of Anaesthesia and Perioperative Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK; William Harvey Research Institute, Queen Mary University of London, London, UK
| | - Gareth L Ackland
- Department of Anaesthesia and Perioperative Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK; William Harvey Research Institute, Queen Mary University of London, London, UK.
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Zhang P, Zhang J, Zhao Y, Chen J, Wang S. Application of Intravenous Chloroprocaine in Gastrointestinal Endoscopy: A Randomized Controlled Trial. Local Reg Anesth 2025; 18:1-8. [PMID: 40177009 PMCID: PMC11960456 DOI: 10.2147/lra.s505804] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/11/2024] [Accepted: 03/25/2025] [Indexed: 04/05/2025] Open
Abstract
Background While propofol is a commonly utilized medication for sedation during gastrointestinal endoscopy, it is associated with adverse effects such as hypotension and injection pain. This trial was conducted to test the hypothesis that chloroprocaine can reduce the requirement for propofol and alleviate injection pain during gastrointestinal endoscopy. Methods Sixty patients undergoing gastrointestinal endoscopy were enrolled and randomly divided into study group (Group CP) and control group (Group C). Patients in Group CP received intravenous chloroprocaine 2 mg/kg, followed by continuous infusion at 6 mg·kg-1·h-1 until the end of examination. Patients in Group C received the same volume of saline. Subsequently, all patients were intravenously administered sufentanil at a dose of 0.05 μg/kg. Thirty seconds later, propofol was uniformly infused intravenously at a rate of 60 mL/min using an infusion pump. The primary outcome was the consumption of propofol. Secondary outcomes included the incidence of hypoxemia, hypotension, bradycardia, injection pain, and coughing/body movement during examination. The recovery time, PACU stay time, postoperative pain score, and endoscopists' satisfaction score were also recorded. Results Group CP demonstrated a significantly lower total requirement for propofol compared to Group C, with means of (119±14) mg and (148±18) mg respectively, P<0.001. This trend was also observed for both the first and supplemental doses. There were no significant differences between the two groups regarding intraoperative adverse events. The incidence of injection pain in Group CP was lower than that in Group C (P=0.007). The recovery time [(4.7±1.4) vs (6.6±1.3), P<0.001], PACU stay time [(13.0±2.9) vs (16.7±3.0), P<0.001] and postoperative pain score [(1.9±0.7) vs (2.5±0.7), P=0.002] in Group CP were lower than those in Group C. Conclusion Intravenous chloroprocaine reduces the requirement for propofol, alleviates propofol injection pain, and improves recovery in patients undergoing gastrointestinal endoscopy.
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Affiliation(s)
- Peng Zhang
- Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China
| | - Jin Zhang
- Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China
| | - Ying Zhao
- Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China
| | - Jun Chen
- Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China
| | - Shaolin Wang
- Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China
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Pavlidi A, Triki L, Mortier J, Deviere J, Lemmers A, Huberty V, Forget P, Hannen M, Quolin C, Tuna T, Blero D, Arvanitakis M. Impact of virtual reality distraction during colonoscopy vs intravenous deep sedation: Results of a single-center randomized controlled trial. Endosc Int Open 2025; 13:a25209768. [PMID: 40109310 PMCID: PMC11922172 DOI: 10.1055/a-2520-9768] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2024] [Accepted: 01/13/2025] [Indexed: 03/22/2025] Open
Abstract
Background and study aims Colonoscopy is associated with discomfort that requires intravenous sedation (IVS). The aim of this randomized controlled trial (RCT) was to explore the feasibility of virtual reality distraction (VRD) for colonoscopy using two primary endpoints: cecal intubation rate and the rate of rescue with IVS. Patients and methods Patients scheduled for elective colonoscopy with IVS were randomized in a 2:1 ratio in favor of VRD, with rescue IVS by propofol if needed. VRD involved use of a device providing a visual and auditive experience similar to clinical hypnosis. Results Ninety patients were included (VRD:60, IVS: 30). Cecal intubation rate was similar in both groups (92.8% for VRD vs 100% for IVS, P =0.3). The rate of rescue IVS in the VRD group was 63.6%. There was a decrease in median total dose of propofol per patient in the VRD group (1.15 mg/kg for VRD and 4.41 mg/kg for IVS, P <0.001) and in the subgroup of VRD patients who received IVS rescue (3.17 mg/kg for VRD and 4.41 mg/kg for IVS, P =0.003). The median level of pain was higher and the median level of comfort was lower in the VRD group (respectively 3 vs 0, P <0.001 and 7 vs 10, P <0.001). Conclusions This RCT provides preliminary data to better understand the feasibility of VRD for colonoscopy. We have not identified differences in procedure outcomes compared with conventional IVS, but nevertheless, higher pain and lower comfort scores were reported.
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Affiliation(s)
- Anastasia Pavlidi
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Lotfi Triki
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Julien Mortier
- Department of Anesthesiology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Jacques Deviere
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Arnaud Lemmers
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Vincent Huberty
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | - Patrice Forget
- Anaesthesia, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Department of Anaesthesia, NHS Grampian, Aberdeen, United Kingdom, Aberdeen, United Kingdom of Great Britain and Northern Ireland
| | - Mark Hannen
- Anaesthesia, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Department of Anaesthesia, NHS Grampian, Aberdeen, United Kingdom, Aberdeen, United Kingdom of Great Britain and Northern Ireland
| | - Caroline Quolin
- European Organisation for Research and Treatment in Cancer (EORTC), Brussels, Belgium
| | - Turgay Tuna
- Department of Anesthesiology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
| | | | - Marianna Arvanitakis
- Department of Gastroenterology, Digestive Oncology and Hepatopancreatology, HUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium
- Research Unit in Cardio-Respiratory Physiology and Exercise Nutrition, Faculty of Human Movement Sciences, Université libre de Bruxelles, Brussels, Belgium
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Xin Y, Lu P, Guan S, Si S, Sun R, Xia W, Xu H. Efficacy and Safety of Remimazolam in Short Endoscopic Procedures: A Systematic Review and Meta-Analysis. MEDICINA (KAUNAS, LITHUANIA) 2025; 61:453. [PMID: 40142264 PMCID: PMC11943698 DOI: 10.3390/medicina61030453] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/29/2025] [Revised: 02/23/2025] [Accepted: 02/27/2025] [Indexed: 03/28/2025]
Abstract
Background and Objectives: Appropriate sedation and anesthesia are crucial for ensuring comfortable endoscopic procedures. Propofol is one of the most often used sedatives. However, its safety and adverse effects restrict its usage. Remimazolam is a relatively new intravenous benzodiazepine that offers many benefits. Our analysis aims to evaluate the effectiveness and safety of remimazolam during short endoscopic procedures. Materials and Methods: We conducted a comprehensive search of the PubMed, Web of Science, ClinicalTrials.gov, and Turning Research Into Practice databases up to 31 December 2023, for randomized controlled trials published in English. Statistical analyses were performed using Cochrane Review Manager 5.4.1 and Stata Software/MP. Results: The success rate of sedation with remimazolam was slightly lower than that with propofol (RR: 0.99, 95% CI: 0.98~1.00; p = 0.004; I2 = 42%). As for anesthetic effect-related outcomes, remimazolam did not show advantages in onset time (MD = 12.72, 95% CI: 6.53~18.90, p < 0.001, I2 = 94%), recovery time (MD = 0.86, 95% CI: -0.55~2.27, p = 0.23, I2 = 98%), or intraoperative body movement (RR: 1.18, 95% CI: 0.60~2.32, p = 0.62, I2 = 87%). However, compared to propofol, remimazolam significantly reduced the incidence of several adverse events, including injection pain (RR: 0.07, 95% CI: 0.03~0.14, p < 0.001, I2 = 69%), intraoperative hypotension (RR: 0.38, 95% CI: 0.31~0.47, p < 0.001, I2 = 65%), bradycardia (RR: 0.25, 95% CI: 0.15~0.45, p < 0.001, I2 = 0%), and respiratory depression (RR: 0.34, 95% CI: 0.25~0.46, p < 0.001, I2 = 50%). The incidence of postoperative nausea and vomiting (PONV) was slightly higher with remimazolam (RD: 0.01, 95% CI: 0.00~0.03, p = 0.04, I2 = 33%). Conclusions: Remimazolam is a promising sedative for short endoscopic procedures due to its superior safety profile despite a slightly lower sedation success rate compared to propofol.
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Affiliation(s)
| | | | | | | | | | - Wei Xia
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
| | - Hui Xu
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
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Xie D, Zhang Y, Li F, Yang Y, Che M, Li G, Zhang Y. Efficacy and safety of ciprofol for gastroscopy in patients with obesity: a randomised clinical controlled trial using different weight-based dosing scales. BMC Anesthesiol 2025; 25:112. [PMID: 40025458 PMCID: PMC11874440 DOI: 10.1186/s12871-025-02974-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/20/2024] [Accepted: 02/14/2025] [Indexed: 03/04/2025] Open
Abstract
BACKGROUND This study aimed to compare the efficacy and safety of ciprofol-induced doses based on three indices: total body weight (TBW), ideal body weight (IBW), and lean body weight (LBW) in patients with obesity undergoing gastroscopy. METHODS In a single-centre, prospective, randomised study conducted at an endoscopy centre, a total of 108 patients aged 18-65 years who underwent painless gastroscopy and had a body mass index (BMI) of 28-39.9 kg/m2 were included. Patients with obesity from the intended study population were randomised to receive a ciprofol infusion (0.4 mg/kg) for the induction of anaesthesia based on TBW (Group T), IBW (Group I), or LBW (Group L). A Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale score of < 1 was considered a marker of loss of consciousness, prompting gastroscopy. The primary outcomes were the success rate of anaesthesia for the procedures, and that of general anaesthesia achieved using the initial dose. Secondary outcomes included the frequency of remedial sedation, total ciprofol dose, and adverse events RESULTS: The procedure success rate was 100% in all three groups. Compared to Group L, the general anaesthesia success rate achieved with the initial dose was higher and the frequency of remedial sedation was lower in Groups T and I. Compared to Group L, fewer patients in Group T required additional medication. Compared to Group T, the occurrence of hypoxaemia was lower in the remaining two groups, and Group L had a lower incidence of posterior tongue drops and hypotension. CONCLUSIONS Induction doses of ciprofol based on TBW or IBW provided better anaesthesia than doses based on LBW for gastroscopy in patients with obesity. LBW-based induction doses of ciprofol improved cardiovascular stability and respiratory safety, whereas IBW-based induction doses of ciprofol reduced respiratory depression. TRIAL REGISTRATION This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300073539 first registration date 13/07/2023).
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Affiliation(s)
- Danru Xie
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Yanjing Zhang
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Feifei Li
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Yaoheng Yang
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Mengjiao Che
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Geng Li
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China
| | - Yiwen Zhang
- Department of Anaesthesiology, Shunde Hospital of Southern Medical University The First People's Hospital, Shunde District, Foshan City, Foshan, 528308, China.
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Qi J, Zhang L, Meng F, Yang X, Chen B, Gao L, Zhao X, Luo M. Comparative effects of ciprofol and propofol on perioperative outcomes: a systematic review and meta-analysis of randomized controlled trials. BRAZILIAN JOURNAL OF ANESTHESIOLOGY (ELSEVIER) 2025; 75:844578. [PMID: 39608601 PMCID: PMC11699592 DOI: 10.1016/j.bjane.2024.844578] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/03/2024] [Revised: 11/07/2024] [Accepted: 11/09/2024] [Indexed: 11/30/2024]
Abstract
BACKGROUND The ideal anesthetic agents for sedation, considering their respiratory and cardiovascular benefits and other perioperative or postoperative outcomes, are still unclear. This systematic review and meta-analysis aimed to evaluate whether ciprofol has advantages over propofol for sedation, particularly concerning respiratory and cardiovascular outcomes and other relevant perioperative measures. METHODS We conducted a comprehensive search of PubMed, Web of Science, the Cochrane Central Register of Controlled Trials, and two Chinese databases for randomized controlled trials comparing intravenous ciprofol and propofol for sedation. The primary outcome was the incidence of adverse respiratory events. Secondary outcomes included incidences of injection pain, hypotension, hypertension, bradycardia during surgery, perioperative nausea and vomiting, and postoperative awakening time. A random-effects model was used for more than four studies; otherwise, we employed the random-effects model with the Hartung-Knapp-Sidik-Jonkman adjustment. RESULTS Intravenous ciprofol resulted in fewer adverse respiratory events than propofol (Risk Ratio [RR = 0.44]; 95% Confidence Interval [95% CI 0.35-0.55], p < 0.001, I2 = 45%, low quality). It also showed a lower incidence of injection pain (RR = 0.12; 95% CI 0.08‒0.17, p < 0.001, I2 = 36%, low quality), intraoperative hypotension (RR = 0.64; 95% CI 0.52-0.77, p < 0.001, I2 = 58%, low quality), and nausea and vomiting than propofol (RR = 0.67; 95% CI 0.49-0.92; p = 0.01, I2 = 0%, moderate quality). However, no significant differences were observed for hypertension, bradycardia, and awakening time. CONCLUSIONS Ciprofol may be more effective than propofol in minimizing perioperative respiratory adverse events and maintaining hemodynamic stability during sedation without prolonging recovery time.
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Affiliation(s)
- Jiazheng Qi
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Lingjing Zhang
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Fanhua Meng
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Xiaoyu Yang
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Baoxuan Chen
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Lingqi Gao
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China
| | - Xu Zhao
- Sun Yat-sen University, The First Affiliated Hospital, Department of Anesthesiology, Guangzhou, China
| | - Mengqiang Luo
- Fudan University, Huashan Hospital, Department of Anesthesiology, Shanghai, China.
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Luo HR, Chen AD, Lin JF, Ye P, Chen YJ, Lin MX, Chen PZ, Chen XH, Zheng XC. Effect of etomidate added to propofol target-controlled infusion in bidirectional endoscopy: A randomized clinical trial. World J Gastrointest Endosc 2025; 17:100722. [PMID: 39989856 PMCID: PMC11843041 DOI: 10.4253/wjge.v17.i2.100722] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Revised: 01/06/2025] [Accepted: 01/18/2025] [Indexed: 02/13/2025] Open
Abstract
BACKGROUND Propofol has been widely used in bidirectional gastrointestinal endoscopy sedation; however, it frequently leads to cardiovascular adverse events and respiratory depression. Propofol target-controlled infusion (TCI) can provide safe sedation but may require higher dosages of propofol. On the contrary, etomidate offers hemodynamic stability. AIM To evaluate the effect of different dose etomidate added to propofol TCI sedation during same-visit bidirectional endoscopy. METHODS A total of 330 patients from Fujian Provincial Hospital were randomly divided into three groups: P, 0.1EP, and 0.15EP. Patients in the P group received propofol TCI only, with an initial effect-site concentration of the propofol TCI system of 3.0 mg/mL. Patients in the 0.1EP and 0.15EP groups received 0.1 and 0.15 mg/kg etomidate intravenous injection, respectively, followed by propofol TCI. RESULTS Patients in the 0.15EP group had higher mean blood pressure after induction than the other groups (P group: 78 mmHg, 0.1EP group: 82 mmHg, 0.15EP group: 88 mmHg; P < 0.05). Total doses of propofol consumption significantly decreased in the 0.15EP group compared with that in the other groups (P group: 260.6 mg, 0.1EP group: 228.1 mg, 0.15EP group: 201.2 mg; P < 0.05). The induction time was longer in the P group than in the other groups (P group: 1.9 ± 0.7 minutes, 0.1EP group: 1.2 ± 0.4 minutes, 0.15EP group: 1.1 ± 0.3 minutes; P < 0.01). The recovery time was shorter in the 0.15EP group than in the other groups (P group: 4.8 ± 2.1 minutes, 0.1EP group: 4.5 ± 1.6 minutes, 0.15EP group: 3.9 ± 1.4 minutes; P < 0.01). The incidence of hypotension (P group: 36.4%, 0.1EP group: 29.1%, 0.15EP group: 11.8%; P < 0.01) and injection pain was lower in the 0.15EP group than in the other groups (P < 0.05). Furthermore, the incidence of respiratory depression was lower in the 0.15EP group than in the P group (P < 0.05). Additionally, the satisfaction of the patient, endoscopist, and anesthesiologist was higher in the 0.15EP group than in the other groups (P < 0.05). CONCLUSION Our findings suggest that 0.15 mg/kg etomidate plus propofol TCI can significantly reduce propofol consumption, which is followed by fewer cardiovascular adverse events and respiratory depression, along with higher patient, endoscopist, and anesthesiologist satisfaction.
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Affiliation(s)
- Hui-Rong Luo
- Department of Anesthesiology, Fujian Medical University Union Hospital, Fuzhou 350000, Fujian Province, China
| | - An-Di Chen
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Jing-Fang Lin
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Peng Ye
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Ying-Jie Chen
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Ming-Xue Lin
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Pin-Zhong Chen
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Xiao-Hui Chen
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
| | - Xiao-Chun Zheng
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fuzhou 350000, Fujian Province, China
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Zong J, Yuan P, Zhang R, Wu S, Liu M, Qu L. Effect of remimazolam tosylate on the response to endotracheal intubation under general anesthesia in patients undergoing catheter placement for peritoneal dialysis. Am J Transl Res 2025; 17:974-982. [PMID: 40092091 PMCID: PMC11909564 DOI: 10.62347/xwsd5681] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2024] [Accepted: 01/18/2025] [Indexed: 03/19/2025]
Abstract
OBJECTIVE This study aims to observe the effects of remimazolam tosylate on the response to endotracheal intubation under general anesthesia in patients undergoing peritoneal dialysis catheter placement. Additionally, we seek to determine the 95% effective dose (ED95) of remimazolam tosylate for inhibiting the endotracheal intubation response in this patient population. METHODS This prospective study was registered with the China Clinical Trials Center (ChiCTR2200055709), https://www.chictr.org.cn/showproj.html?proj=149640. Patients scheduled for peritoneal dialysis catheter placement under general anesthesia at the First Affiliated Hospital of Nanchang University between January and June 2023 were selected. They were randomly assigned into the remimazolam tosylate group (R group) and the propofol group (P group), with 30 patients in each group. After anesthesia induction and subsequent endotracheal intubation, sedation efficacy and adverse reactions were recorded for both groups. Venous blood samples (1 mL) were collected from patients before anesthesia induction and after endotracheal intubation to measure levels of adrenaline and noradrenaline. The modified Dixon sequential method was used to determine the ED95 of remimazolam tosylate for inhibiting the endotracheal intubation response. RESULTS Levels of adrenaline and noradrenaline decreased significantly after endotracheal intubation in both the R group and P group, with no significant difference. Vital signs were more stable in the R group compared to the P group. Injection pain during anesthesia induction was reported in 3 patients (10%) in the R group, whereas 18 cases (60%) were observed in the P group. The Dixon sequential experiment included a total of 25 patients, with 13 (52%) showing positive responses and 12 (48%) negative responses. CONCLUSIONS Remimazolam tosylate is effective for inhibiting the systemic response to endotracheal intubation in patients undergoing peritoneal dialysis catheter placement. Additionally, the occurrence rate of hypotension and injection pain during anesthesia induction is significantly lower compared to propofol. The ED95 of remimazolam tosylate for inhibiting the endotracheal intubation response in peritoneal dialysis catheter placement patients is 0.332 mg/kg.
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Affiliation(s)
- Jing Zong
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
- Department of Anesthesiology, Ganjiang New Area People's Hospital Nanchang 330001, Jiangxi, China
| | - Peihua Yuan
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
| | - Ruijiao Zhang
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
| | - Shiyin Wu
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
| | - Mei Liu
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
| | - Liangchao Qu
- Department of Anesthesiology and Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University Nanchang 330001, Jiangxi, China
- Department of Anesthesiology, Ganjiang New Area People's Hospital Nanchang 330001, Jiangxi, China
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11
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Zhou Z, Li Y, Zhu J, Liu Y, Wang Y, Sang X, Wang X, Zhang X. Role of the inferior vena cava collapsibility index in predicting propofol-induced hypotension in patients undergoing colonoscopy. BMC Anesthesiol 2025; 25:73. [PMID: 39953383 PMCID: PMC11827310 DOI: 10.1186/s12871-025-02945-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2024] [Accepted: 02/04/2025] [Indexed: 02/17/2025] Open
Abstract
BACKGROUND Hypotension is a common side effect of propofol induction, and when severe, it is associated with adverse outcomes. Ultrasonography of the inferior vena cava (IVC) is a reliable indicator of the intravascular volume. This study investigated whether preoperative IVC ultrasound measurements could predict hypotension after propofol induction in patients undergoing colonoscopies. METHODS Sixty-two adult patients with American Society of Anesthesiologists physical status (ASA) I-II scheduled for colonoscopy after propofol induction were recruited. The Ultrasound Maximum IVC diameter (dIVCmax), minimum IVC diameter (dIVCmin), and collapsibility index (IVC-CI) were assessed in all patients before propofol induction. Mean blood pressure (MBP) was recorded before induction. Propofol was injected intravenously after ultrasound measurements. MBP was recorded 1, 3, 5, and 10 min after propofol induction. The receiver operating characteristic (ROC) curve of IVC-CI was compared with that of patients who developed hypotension after propofol induction. RESULTS Sixty-two patients completed the study, and their data were considered for statistical analysis. After induction,30 patients developed hypotension. The area under the curve (95% confidence interval) was 0.72 (0.595 to 0.849) for IVC-CI. The optimal IVC-CI cutoff value was 38.25%, with a sensitivity of 56.7% and specificity of 71.9%. IVC-CI before induction strongly correlated with the maximum percentage of MBP drop after propofol induction. (regression coefficient = 0.33, P = 0.008), respectively. CONCLUSION Pre-induction IVC-CI > 38.25% is a non-invasive predictor of propofol-induced hypotension in patients undergoing colonoscopy and is strongly correlated with MBP drop. TRIAL REGISTRATION This clinical trial was approved by the Ethics Committee of The Affiliated Lianyungang Hospital of Xuzhou Medical University (YJ-20190529001). All the study procedures were performed in accordance with the ethical standards of the Helsinki Declaration of 2013.
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Affiliation(s)
- Zhou Zhou
- Department of Anesthesiology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China
| | - Yujie Li
- Department of Anesthesiology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China
| | - Jinxian Zhu
- Lianyungang Maternal and Child Health Hospital, Lianyungang, China
| | - Yingge Liu
- Department of Anesthesiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Yuxin Wang
- Department of Anesthesiology, Lianyungang Clinical College of Nanjing Medical University, Lianyungang, China
| | - Xiaoqiao Sang
- Department of Anesthesiology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China
| | - Xinxin Wang
- Department of Anesthesiology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China
| | - Xiaobao Zhang
- Department of Anesthesiology, The Affiliated Lianyungang Hospital of Xuzhou Medical University, Lianyungang, China.
- Department of Anesthesiology, The First Affiliated Hospital of Kangda College of Nanjing Medical University, Lianyungang, China.
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Tang J, Chen F, Huang J, Li D, Li C. Effect of propofol and ciprofol in patients undergoing bronchoscopy: protocol for a double-blind, randomised controlled trial. BMJ Open 2025; 15:e083068. [PMID: 39843383 PMCID: PMC11758696 DOI: 10.1136/bmjopen-2023-083068] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2023] [Accepted: 12/12/2024] [Indexed: 01/30/2025] Open
Abstract
INTRODUCTION Propofol is a fast-acting intravenous anaesthetic widely used for sedation and anaesthesia in gastrointestinal endoscopy, bronchoscopy, and the induction/maintenance of general anaesthesia in outpatients and inpatients; however, propofol has several undesirable effects, including injection pain, which affects the physical and mental health of patients, and cardiopulmonary depression, characterised by hypotension, bradycardia and apnea, which commonly occur in clinical practice. Ciprofol (HSK3486) is a propofol analogue with good clinical safety, high potency and some advantages over propofol, including lower injection pain and haemodynamic depression in patients undergoing gastroscopy and colonoscopy. This study aims to compare the impact of equivalent effective doses of propofol and ciprofol on haemodynamic changes in patients undergoing bronchoscopy under general anaesthesia. METHODS This prospective, double-blind, randomised, controlled clinical trial will recruit 250 patients aged 18-80 years scheduled for elective bronchoscopy under general anaesthesia. The cohort will be randomised into two groups in a 1:1 ratio: propofol (200 mg/20 mL of saline) and ciprofol (40 mg/20 mL of saline). The primary outcomes are changes in heart rate and blood pressure before and after induction, laryngeal mask airway (LMA) placement and bronchoscopy placement. The secondary outcomes are the incidence of choking and injection pain, the type and dose of vasoactive drugs used during the operation, and the level of postoperative satisfaction among surgeons, anaesthesiologists and patients. ETHICS AND DISSEMINATION This trial was approved by the Medical Ethics Committee of Shanghai Fourth People's Hospital, School of Medicine, Tongji University and registered with the Chinese Clinical Trials Registry (Identifier: ChiCTR2200063048) on 29 August 2022. The findings of this study will be disseminated through various channels. Academic dissemination will include publication in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER ChiCTR2200063048.
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Affiliation(s)
- Jinxuan Tang
- Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China
- Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China
| | - Fang Chen
- Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China
| | - Jiayu Huang
- Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China
| | - Dongliang Li
- Discipline Planning Department, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Cheng Li
- Department of Anesthesiology and Perioperative medicine, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Clinical Research Center for Anesthesiology and Perioperative Medicine, Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, People's Republic of China
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13
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Liu D, Gao X, Zhuo Y, Cheng W, Yang Y, Wu X, Yang H, Yao Y. Effect of Esketamine on Cognitive Recovery After Propofol Sedation for Outpatient Colonoscopy: A Randomized Clinical Trial. Drug Des Devel Ther 2025; 19:425-437. [PMID: 39867863 PMCID: PMC11762454 DOI: 10.2147/dddt.s503129] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/26/2024] [Accepted: 01/14/2025] [Indexed: 01/28/2025] Open
Abstract
Purpose While esketamine shows promise as an adjunct in procedural sedation, its impact on postoperative cognitive recovery remains incompletely characterized. This study investigated the effects of esketamine on multiple dimensions of recovery, particularly cognition, in patients undergoing colonoscopy with propofol-based sedation. Patients and Methods We conducted this randomized, double-blinded, placebo-controlled trial from January 6, 2023, to May 20, 2024, at two hospitals in China. Patients were randomized in a 1:1 ratio to receive either esketamine 0.2 mg/kg (n = 126) or placebo (n = 126), followed by propofol 1 mg/kg. We administered additional propofol boluses (0.5 mg/kg) to maintain sedation. The study assessed cognitive recovery on postoperative day 3 as the primary outcome, measured by the Postoperative Quality of Recovery Scale (PostopQRS). Secondary outcomes included overall recovery, recovery in other PostopQRS domains, time to discharge, and adverse events. Results Esketamine significantly enhanced cognitive recovery compared to placebo on postoperative day 3 (95.2% vs 83.3%, relative risk = 1.14; 95% confidence interval: 1.05-1.25, P = 0.002). Discharge times were comparable between groups (odds ratio = 0.70; 95% confidence interval: 0.43-1.16, P = 0.163). The esketamine group demonstrated higher satisfaction (P = 0.003) and significantly reduced incidences of hypotension (14.3% vs 36.5%, P < 0.001), bradycardia (5.6% vs 15.1%, P = 0.013), hypoxemia (2.4% vs 8.7%, P = 0.028), and injection site pain (21.4% vs 48.4%, P < 0.001). Conclusion Adding esketamine 0.2 mg/kg to propofol for colonoscopy sedation improved postoperative cognitive recovery, enhanced patient satisfaction, and reduced cardiopulmonary adverse events without prolonging discharge time. These findings establish low-dose esketamine as a beneficial adjunct to propofol in procedural sedation for colonoscopy.
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Affiliation(s)
- Deshan Liu
- Department of Neurology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People’s Republic of China
| | - Xiuchai Gao
- Department of Anesthesiology, Fujian Xiapu County Hospital, Xiapu, Fujian, People’s Republic of China
| | - Yifen Zhuo
- Department of Anesthesiology, Xiamen Haicang Hospital, Xiamen, Fujian, People’s Republic of China
| | - Wanjie Cheng
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People’s Republic of China
| | - Ying Yang
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People’s Republic of China
| | - Xiaoyan Wu
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People’s Republic of China
| | - Huobao Yang
- Fujian Provincial Key Laboratory of Critical Care Medicine, Fuzhou, Fujian, People’s Republic of China
| | - Yusheng Yao
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, People’s Republic of China
- Fujian Provincial Key Laboratory of Critical Care Medicine, Fuzhou, Fujian, People’s Republic of China
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Shebl MA, Toraih E, Shebl M, Tolba AM, Ahmed P, Banga HS, Orz M, Tammam M, Saadalla K, Elsayed M, Kamal M, Abdulla M, Eldessouky AI, Moustafa YT, Mohamed OA, Aiash H. Preoperative anxiety and its impact on surgical outcomes: A systematic review and meta-analysis. J Clin Transl Sci 2025; 9:e33. [PMID: 40052059 PMCID: PMC11883570 DOI: 10.1017/cts.2025.6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2024] [Revised: 12/25/2024] [Accepted: 01/10/2025] [Indexed: 03/09/2025] Open
Abstract
Background Preoperative anxiety is a common phenomenon affecting 60-80% of surgical patients, with potential implications for surgical outcomes. Despite its prevalence, there remains a lack of consensus on its precise effects and optimal management strategies. Objective This meta-analysis aimed to synthesize current evidence on the impact of preoperative anxiety on various surgical outcomes, including anesthetic and analgesic requirements, delirium, recovery times, and pain. Methods We conducted a comprehensive literature search and meta-analysis of studies examining the relationship between preoperative anxiety and surgical outcomes. Standardized mean differences (SMD), correlation (COR), and odds ratios (OR) with 95% confidence intervals were calculated. Results Our analysis revealed significant associations between preoperative anxiety and increased anesthetic requirements (SMD = 0.67, 95% CI: 0.32-1.01) and analgesic requirements (SMD = 0.89, 95% CI: 0.65-1.12). Preoperative anxiety was associated with postoperative delirium in adults (OR = 1.90, 95% CI: 1.11-3.26), unlike the pediatric population. Preoperative anxiety was associated with prolonged time to reach Modified Aldrete Score of 9 (SMD = 0.79, 95% CI: 0.50-1.07) and extubation time (SMD = 0.89, 95% CI: 0.58-1.21). Preoperative anxiety was positively correlated with propofol consumption (STAI-S COR = 0.35, 95%CI: 0.15-0.55). No significant association between preoperative anxiety and postoperative pain was found. Conclusions This meta-analysis provides evidence for the wide-ranging effects of preoperative anxiety on surgical outcomes. The findings emphasize the need for routine preoperative anxiety screening and the development of targeted interventions. Future research should focus on long-term impacts and the effectiveness of various anxiety management strategies.
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Affiliation(s)
- Mohamed A. Shebl
- Faculty of Medicine, Cairo University, Kasr Al-Ainy, Cairo, Egypt
| | - Eman Toraih
- Tulane University School of Medicine, New Orleans, LA, USA
- Faculty of Medicine, Suez Canal University, Ismailia, Egypt
- Upstate Medical University, Syracuse, USA
| | - Menna Shebl
- Faculty of Medicine, Modern University for Technology and Information, Cairo, Egypt
| | | | | | | | - Mohab Orz
- Faculty of Medicine, Alexandria University, Alexandria, Egypt
| | - Mahmoud Tammam
- Faculty of Medicine, Alexandria University, Alexandria, Egypt
| | - Keroles Saadalla
- Faculty of Medicine, Cairo University, Kasr Al-Ainy, Cairo, Egypt
| | - Mohamed Elsayed
- Dnipropetrovsk Medical Institute of Conventional and Alternative Medicine, Dnipropetrovsk, Ukraine
| | | | - Mohamed Abdulla
- Faculty of Medicine, Alexandria University, Alexandria, Egypt
| | | | | | | | - Hani Aiash
- Faculty of Medicine, Suez Canal University, Ismailia, Egypt
- Upstate Medical University, Syracuse, USA
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15
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Tian Y, Li J, Jin M, Piao Y, Sheng J, Mei Z, Cui Q, Li L. Procedural sedative effect of remimazolam in ICU patients on invasive mechanical ventilation: a randomised, prospective study. Ann Intensive Care 2025; 15:8. [PMID: 39808218 PMCID: PMC11732822 DOI: 10.1186/s13613-025-01431-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Accepted: 01/02/2025] [Indexed: 01/16/2025] Open
Abstract
BACKGROUND Invasive procedures and environmental factors in the intensive care unit (ICU) may cause anxiety and discomfort in patients, who often require sedation therapy. The aim of this study was to assess the safety of remimazolam tosilate for procedural sedation in ICU patients receiving mechanical ventilation following endotracheal intubation. Eighty patients from a single centre were randomly assigned to either the propofol group or the remimazolam group. Blood tests were conducted to evaluate changes in lactate, blood lipids, liver and kidney function, and inflammatory markers, and patients' vital signs were observed over several periods. This study compared the incidence of delirium, the impact on liver and kidney function, circulatory effects, and changes in blood lipids between the two groups. These findings have optimised the selection of medications, providing ICU patients with more options for sedation therapy. METHODS In this single-centre randomised controlled trial, intubated patients were randomly assigned to the remimazolam group or the propofol group. Under the same analgesic regimen, the two groups received remimazolam and propofol for procedural sedation. RESULTS Our primary outcome was the mean arterial pressure (MAP), which significantly differed on Days 4 and 7 (P = 0.021, control group vs. experimental group = 85.23 ± 11.24 vs. 94.36 ± 13.18, P = 0.023, 83.55 ± 8.94 vs. 92.66 ± 7.02). With respect to liver and kidney function, the ∆AST value in the remimazolam group was significantly lower than that in the control group on Day 7 (P = 0.023). There were significant differences in triglyceride (TG) levels on Days 4 and 7 (P = 0.020) and in the ∆LDL on Day 7 (P = 0.027). Furthermore, the rates of dyslipidaemia and delirium in the remimazolam group were lower than those in the propofol group (85.0%, n = 40 vs. 90.0%, n = 40; 27.5%, n = 40 vs. 55%, n = 40). CONCLUSION Remimazolam is a novel benzodiazepine that has demonstrated promising applications in general anaesthesia and procedural sedation; however, its use in ICU sedation is still in the early stages of research. Current evidence suggests that remimazolam is a safe sedative that is particularly well suited for patients with haemodynamic instability. Large sample-size randomised clinical trials are warranted.
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Affiliation(s)
- Youli Tian
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
- Department of Intensive Care Unit, Linyi People's Hospital, Shandong, 276000, China
| | - Jintong Li
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
| | - Minggen Jin
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
| | - YiHua Piao
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
| | - Jisheng Sheng
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
| | - Zhixiong Mei
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China
| | - Qingsong Cui
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China.
| | - Lilin Li
- Department of Intensive Care Unit, Yanbian University Hospital, No. 1327, Juzi Street, Xinxing Street, Yanji, 136200, Jilin, China.
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16
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Liao M, Wu XR, Hu JN, Lin XZ, Zhao TYM, Sun H. Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation. Sci Rep 2025; 15:1822. [PMID: 39805976 PMCID: PMC11730606 DOI: 10.1038/s41598-025-85968-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/28/2024] [Accepted: 01/07/2025] [Indexed: 01/30/2025] Open
Abstract
Ciprofol, a novel γ-aminobutyric acid receptor agonist, outperforms propofol with minimal cardiovascular effects, higher potency, reduced injection pain, and a broader safety margin. Despite these advantages, ciprofol's clinical research is still emerging. This study compares the median effective dose (ED50) and adverse reactions of ciprofol and propofol, in conjunction with sufentanil, for suppressing cardiovascular responses during tracheal intubation. Fifty-three adult patients scheduled for tracheal intubation under general anesthesia were enrolled and randomly assigned to receive either ciprofol (Group C) or propofol (Group P), according to a random number table. Tracheal intubation was performed using a standardized laryngoscope and endotracheal tube. The Dixon's up-and-down method was employed to determine the ED50 and 95% effective dose (ED95) of ciprofol and propofol in inhibiting cardiovascular responses during tracheal intubation. Based on the pilot study, the initial dose for ciprofol was set at 0.35 mg/kg (with a 0.01 mg/kg increment) and for propofol at 2.0 mg/kg (with a 0.1 mg/kg increment). Probit analysis was applied to derive dose-response curves, while adverse reactions were continuously monitored. A total of 54 participants were included, with 24 in group C (1 excluded) and 30 in group P. Probit analysis revealed that the ED50 of ciprofol for inhibiting cardiovascular responses to tracheal intubation were 0.326 mg/kg (95% CI 0.304-0.337 mg/kg), and for propofol, 1.541 mg/kg (95% CI 1.481-1.599 mg/kg). The heart rate in group P was significantly higher than the group C at 1 minute (p = 0.026) and 3 minutes (p = 0.016) post-intubation. Systolic and diastolic blood pressures (SBP and DBP) decreased significantly before and after intubation compared to baseline values in both groups (p< 0.05). Group C experienced significantly less injection pain (p = 0.001), although the incidence of other adverse effects was not statistically different between groups (p > 0.05).Clinical Trial Registration: hppts://ClinicalTrials.gov; Identifier: NCT06095570(18/10/2023).
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Affiliation(s)
- Min Liao
- The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
| | - Xiao-Ru Wu
- The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
| | - Jia-Ning Hu
- The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
| | - Xing-Zhou Lin
- The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China
| | | | - Hu Sun
- The Second Affiliated Hospital of Hainan Medical University, Hai Kou, China.
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Guan Y, Li B, Zhang Y, Luo H, Wang X, Bai X, Zheng Z, Huang Y, Wei W, Huang M, Song X, Zhong G. Pharmacogenetic and pharmacokinetic factors for dexmedetomidine-associated hemodynamic instability in pediatric patients. Front Pharmacol 2025; 15:1515523. [PMID: 39840108 PMCID: PMC11745869 DOI: 10.3389/fphar.2024.1515523] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2024] [Accepted: 11/25/2024] [Indexed: 01/23/2025] Open
Abstract
Purpose The incidence of hemodynamic instability associated with dexmedetomidine (DEX) sedation has been reported to exceed 50%, with substantial inter-individual variability in response. Genetic factors have been suggested to contribute significantly to such variation. The aim of this study was to identify the clinical, pharmacokinetic, and genetic factors associated with DEX-induced hemodynamic instability in pediatric anesthesia patients. Methods A cohort of 270 pediatric patients scheduled for elective interventional surgery received an intranasal dose of 3 mcg·kg-1 of dexmedetomidine, and subsequent propofol induction was conducted when patients had a UMSS of 2-4. The primary endpoint was hemodynamic instability-defined as a composite of hypotension and/or bradycardia, which is characterized by a 20% reduction from age-specific baseline values. Plasma concentrations of dexmedetomidine were determined, and single-nucleotide polymorphisms (SNPs) were genotyped. A validated population pharmacokinetic model was used to estimate pharmacokinetic parameters. LASSO regression was used to identify significant factors, and a Cox's proportional hazards model-derived nomogram for hemodynamic instability was developed. Results Hemodynamic instability was observed in 52 out of 270 patients (209 events), resulting in a cumulative incidence of 16.30% at 90 min, as estimated by Kaplan-Meier estimation, and it was associated with a median time to event of 35 min. The interval time between DEX initiation and propofol induction was 16 min (IQR: 12-22 min). The cumulative incidence was 8.2% within 22 min after DEX initiation. The identified significant risk factors for DEX-associated hemodynamic instability included weight, DEX clearance, concomitant propofol use, and the following gene variants UGT2B10 rs1841042 (hazard ratio (HR):1.41, 95% confidence interval (CI): 1.12-1.79), CYP2A6 rs8192733 (HR:0.28, 95%CI:0.09-0.88), ADRA2B rs3813662 (HR:1.39,95%CI:1.02-1.89), CACNA2D2 rs2236957 (HR:1.46, 95%CI:1.09-1.96), NR1I2 rs3814057 (HR:0.64, 95%CI:0.43-0.95), and CACNB2 rs10764319 (HR:1.40,95%CI:1.05-1.87). The areas under the curve for the training and test cohorts were 0.881 and 0.762, respectively. The calibration curve indicated excellent agreement. Conclusion The predictive nomogram, which incorporates genetic variants (UGT2B10, CYP2A6, ADRA2B, CACNA2D2, NR1I2, and CACNB2) along with clinical factors such as weight, DEX clearance, and propofol use, may help prevent DEX-associated hemodynamic instability. Delayed hemodynamic instability is likely to occur after 35-min DEX initiation in patients with lower DEX clearance after propofol induction.
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Affiliation(s)
- Yanping Guan
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
| | - Bilian Li
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Yiyu Zhang
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
| | - Hao Luo
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Xueding Wang
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
| | - Xue Bai
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Zhuoling Zheng
- Department of Pharmacy, Sun Yat-sen University Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
| | - Yaying Huang
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Wei Wei
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Min Huang
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
| | - Xingrong Song
- Department of Anesthesiology, Guangzhou Women and Children’s Medical Center, Guangzhou Medical University, Guangzhou, Guangdong Province, China
| | - Guoping Zhong
- Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
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Li H, Wang J, Wei R, Jiang Y. Median effective dose of remimazolam combined with sufentanil for inhibiting laryngeal mask airway insertion responses in children of different ages. Front Pharmacol 2025; 15:1506209. [PMID: 39834806 PMCID: PMC11743724 DOI: 10.3389/fphar.2024.1506209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2024] [Accepted: 12/09/2024] [Indexed: 01/22/2025] Open
Abstract
Introduction We determined the median effective dose and 95% confidence interval (CI) of remimazolam required to inhibit laryngeal mask airway (LMA) insertion reactions combined with sufentanil 0.3 μg/kg in pediatric anesthesia. Methods Children scheduled to undergo elective laryngeal mask anesthesia were divided into the preschool (age: 3-6 years) and school-age (6-12 years) groups. The timer was started after intravenous remimazolam was administered; thereafter, 0.3 μg/kg sufentanil was injected intravenously. The laryngeal mask was placed 3 min after remimazolam was finished. If a positive response to LMA insertion, such as movement, swallowing, coughing, hiccups, or other reactions, was observed during the insertion, the dose was increased by 0.03 mg/kg for the next patient; if there was no response, the dose was decreased by 0.03 mg/kg instead. The trial officially commenced after the first LMA was successfully inserted and continued until alternating positive and negative responses formed seven crossover points. Thereafter, probit regression was performed to calculate the median effective dose (ED50) and 95% effective dose (ED95) with the corresponding 95% CIs. The time from remimazolam administration to the disappearance of the eyelash reflex was recorded. Heart rate and mean arterial pressure were recorded before (T1, baseline values) and 3 min after (T2) intravenous remimazolam administration. Adverse reactions were also noted. Results Overall, 52 children were included; 25 belonged to the preschool group and 27 to the school-age group. In the preschool group, the ED50 and ED95 for remimazolam and their 95% CIs were 0.476 (0.447-0.517) mg/kg and 0.554 (0.515-0.688) mg/kg, respectively. In the school-age group, the ED50 and ED95 for remimazolam and corresponding 95% CIs were 0.427 (0.399-0.463) mg/kg and 0.504 (0.467-0.635) mg/kg, respectively. The dosage for the preschool group was significantly higher than that for the school-age group (p = 0.003). Conversely, the time from remimazolam administration to the disappearance of the eyelash reflex; LMA insertion success rate; or incidence of coughing, movement, swallowing, and hiccups did not differ significantly between the two groups. Conclusion Remimazolam can be safely used for laryngeal mask anesthesia induction in pediatric patients. Clinical Trial Registration https://www.chictr.org.cn/, identifier ChiCTR2400087333.
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Affiliation(s)
- Hongyun Li
- Department of Anesthesiology, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Jinxia Wang
- Department of Clinical research center, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Rong Wei
- Department of Anesthesiology, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
| | - Yan Jiang
- Department of Anesthesiology, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
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Li R, Wu T, Xu X, Duan X, Wang Y. Deep learning-based discovery of compounds for blood pressure lowering effects. Sci Rep 2025; 15:54. [PMID: 39747442 PMCID: PMC11697042 DOI: 10.1038/s41598-024-83924-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2024] [Accepted: 12/18/2024] [Indexed: 01/04/2025] Open
Abstract
The hypotensive side effects caused by drugs during their use have been a vexing issue. Recent studies have found that deep learning can effectively predict the biological activity of compounds by mining patterns and rules in the data, providing a potential solution for identifying drug side effects. In this study, we established a deep learning-based predictive model, utilizing a data set comprised of compounds known to either elevate or lower blood pressure. Subsequently, the trained model was used to predict the blood pressure-lowering effects of 26,000 compounds. Based on the predicted results, we randomly selected 50 molecules for validation and compared them with literature reports. The results showed that the predictions for 30 molecules were consistent with literature reports, with known antihypertensive drugs such as reserpine, guanethidine, and mecamylamine ranking at the top. We further selected 10 of these molecules and 3 related protein targets for molecular docking, and the docking results indirectly confirmed the model's accuracy. Ultimately, we discovered and validated that salaprinol significantly inhibits ACE1 activity and lowers canine blood pressure. In summary, we have established a highly accurate activity prediction model and confirmed its accuracy in predicting potential blood pressure-lowering compounds, which is expected to help patients avoid hypotensive side effects during clinical medication and also provide significant assistance in the discovery of antihypertensive drugs.
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Affiliation(s)
- Rongzhen Li
- School of Pharmacy, Guilin Medical University, Guilin, 541199, China
| | - Tianchi Wu
- School of Pharmacy, Guilin Medical University, Guilin, 541199, China
| | - Xiaotian Xu
- School of Pharmacy, Guilin Medical University, Guilin, 541199, China
| | - Xiaoqun Duan
- School of Pharmacy, Guilin Medical University, Guilin, 541199, China.
- School of Biomedical Industry, Guilin Medical University, Guilin, 541199, China.
| | - Yuhui Wang
- School of Pharmacy, Guilin Medical University, Guilin, 541199, China.
- School of Biomedical Industry, Guilin Medical University, Guilin, 541199, China.
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20
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Chen W, Xu Y, Zeng Y, Xing G. A meta-analysis and systematic review based on perioperative management of elderly patients: is ciprofol an alternative to propofol? Eur J Clin Pharmacol 2025; 81:111-121. [PMID: 39565391 DOI: 10.1007/s00228-024-03782-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/14/2024] [Accepted: 11/17/2024] [Indexed: 11/21/2024]
Abstract
PURPOSE With the rising number of elderly surgical patients, selecting an appropriate anesthetic tailored to their specific needs is essential. Ciprofol, a novel intravenous anesthetic, has garnered attention due to its low injection pain rate and minimal impact on the circulatory system. This meta-analysis aims to examine the efficacy and safety profile of ciprofol during perioperative management of elderly patients. METHODS Comprehensive searches of PubMed, Embase, Cochrane, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang, and VIP databases from inception to March 23, 2024, were conducted. Eligible studies were included, data extracted, quality assessed using the ROB2 tool, and analyses performed with Stata 17.0. RESULTS Analysis of eleven randomized controlled trials (RCTs) comprising 1715 patients demonstrated that ciprofol outperformed propofol regarding injection pain (RR: 0.13, 95% CI: 0.09-0.20, p < 0.001), hypotension (RR: 0.72; 95% CI: 0.56-0.94; p = 0.014), bradycardia (RR: 0.64, 95% CI: 0.48-0.85, p = 0.002), respiratory depression (RR: 0.29, 95% CI: 0.19-0.43, p < 0.001), hypoxemia (RR: 0.38, 95% CI: 0.26-0.55, p < 0.001), and body movement (RR: 0.73, 95% CI: 0.56-0.96, p = 0.022). No significant differences were observed in induction time(SMD: 0.11,95% CI: -0.39-0.61, p = 0.655), sedative success rate(RR:1.01,,:95% CI:0.97-1.06, p = 0.669)), time of leaving the operating room(SMD-0.21,95% CI: -0.83-0.40, p = 0.497), bucking(RR:0.56,:95% CI:0.27-1.17, p = 0.134)), nausea and vomiting(RR:0.69,95% CI:0.43-1.11, p = 0.143)). CONCLUSION Ciprofol demonstrates comparable efficacy to propofol in general anesthesia for elderly patients, with an enhanced safety profile, making it a viable clinical alternative. Further well-designed large RCTs are required to substantiate its safety profile.
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Affiliation(s)
- Wei Chen
- Department of Anesthesiology, The First Affiliated Hospital of Hunan College of TCM(Hunan Province Directly Affiliated TCM Hospital), No.57l Ren min Middle Road, Zhuzhou, 412000, Hunan, China
| | - YuGuang Xu
- Department of Anesthesiology, The First Affiliated Hospital of Hunan College of TCM(Hunan Province Directly Affiliated TCM Hospital), No.57l Ren min Middle Road, Zhuzhou, 412000, Hunan, China
| | - YaFei Zeng
- Department of Anesthesiology, The First Affiliated Hospital of Hunan College of TCM(Hunan Province Directly Affiliated TCM Hospital), No.57l Ren min Middle Road, Zhuzhou, 412000, Hunan, China
| | - GuiPing Xing
- Department of Anesthesiology, The First Affiliated Hospital of Hunan College of TCM(Hunan Province Directly Affiliated TCM Hospital), No.57l Ren min Middle Road, Zhuzhou, 412000, Hunan, China.
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21
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Martínez-González Ó, Alonso-Fernández MÁ, García-Alonso M, López-Matamala B, Soto-Fernández S, Martín-Parra C, Marín-Alcolado E, Chana-García M, Perez-Grueso MJ, Manso-Álvarez M, de Lucas-Gallego M, Algaba-Calderón Á, Blancas R. Deep sedation for gastrointestinal endoscopy in elderly patients. Subgroup analysis. Dig Liver Dis 2024:S1590-8658(24)01120-4. [PMID: 39710566 DOI: 10.1016/j.dld.2024.11.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2024] [Revised: 10/07/2024] [Accepted: 11/30/2024] [Indexed: 12/24/2024]
Abstract
BACKGROUND Gastrointestinal endoscopy is increasingly performed under sedation in older patients. Aging has implications in increasing the morbidity and the risk of complications related to sedation. The aim of this study is to assess the difference in complications between patients aged 65 to 74 years and those aged over 75 years. MATERIALS AND METHODS A prospective study was designed. Patients older than 65 years under deep sedation were included. Multivariate analysis was performed to assess complications in the propofol-sedated gastroscopy and propofol- and fentanyl-sedated colonoscopy groups. RESULTS 1,225 sedations were performed and 97.3 % of endoscopic procedures were completed. Desaturation occurred in 121 patients (9.9 %) with no significant differences between the two groups, 71 patients in the 65-74 age group and 50 in the ≥75 age group (9.2 % vs 10.9 %; p = 0.336). Major complications requiring intervention occurred in 68 patients (5.6 %), 46 in the 65-74 age group and 22 in the ≥75 age group (6.0 % vs 4.8 %; p = 0.385). Age contributed to the development of complications in gastroscopy under propofol sedation. CONCLUSIONS Complications of gastrointestinal endoscopy under deep sedation in patients older than 65 years are mostly not serious. Deep sedation in patients aged 75 years and older is not associated with more complications than in patients aged 65 to 74 years.
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Affiliation(s)
- Óscar Martínez-González
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | | | - Mónica García-Alonso
- Hospital Universitario del Tajo, Gastroenterology, Department, Universidad Alfonso X el Sabio, Spain.
| | - Blanca López-Matamala
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | | | - Carmen Martín-Parra
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | - Elena Marín-Alcolado
- Hospital Universitario del Tajo, Gastroenterology, Department, Universidad Alfonso X el Sabio, Spain.
| | - Miriam Chana-García
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | | | - Madian Manso-Álvarez
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | | | - Ángela Algaba-Calderón
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
| | - Rafael Blancas
- Hospital Universitario del Tajo, Critical Care, Department, Universidad Alfonso X el Sabio, Spain.
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Muñoz-Carrillo JL, Rodríguez-Cortes N, Lévano ST, Moran-Mariños C, Barboza JJ. Remimazolam Versus Propofol in General Anesthesia of Complex Surgery in Critical and Non-Critical Patients: Meta-Analysis of Randomized Trials. J Clin Med 2024; 13:7791. [PMID: 39768714 PMCID: PMC11728358 DOI: 10.3390/jcm13247791] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2024] [Revised: 11/11/2024] [Accepted: 11/21/2024] [Indexed: 01/16/2025] Open
Abstract
Objective: To compare the efficacy and safety of remimazolam with propofol in general anesthesia in adult patients. Methods: A systematic search in Pubmed, Scopus, Web of Science, and Embase was performed. Patients undergoing complex surgery who were critically ill or non-critically ill were included. The risk of bias (RoB) 2.0 tool was applied. Random-effects models using the inverse variance method were applied for all meta-analyses. Results: Nine randomized controlled trials were included (patients taking remimazolam, n = 678; propofol, n = 454). Remimazolam compared to propofol is likely to produce a large decrease in intraoperative hypotension (RR 0.62, 95% CI 0.50 to 0.76, I2 = 63%, n = 9, CoE moderate certainty), incidence of respiratory depression (RR 0.28, 95% CI 0.09 to 0. 82, I2 = 0%, n = 3; CoE moderate certainty), injection site pain (RR 0.14, 95% CI 0.02 to 0.94, I2 = 21%, n = 4; CoE moderate certainty), and may produce little or no difference in bradycardia (RR 0.61, 95% CI 0.36 to 1.06, I2 = 0%, n = 4; CoE moderate certainty). Conclusions: In patients undergoing complex surgery who are critically ill or non-critically ill, remimazolam, compared with propofol, is likely to produce a large decrease in intraoperative hypotension, incidence of respiratory depression, and injection site pain, but little or no difference in bradycardia is possible.
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Affiliation(s)
- José Luis Muñoz-Carrillo
- Laboratorio de Inmunología, Centro Universitario de los Lagos, Universidad de Guadalajara, Lagos de Moreno, Jalisco 47460, PC, Mexico;
| | | | | | - Cristian Moran-Mariños
- Unidad de Investigación en Bibliometría, Vicerrectorado de Investigación, Universidad San Ignacio de Loyola, Lima 15024, PC, Peru;
| | - Joshuan J. Barboza
- Escuela de Medicina, Universidad Señor de Sipán, Chiclayo 14001, PC, Peru
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Lin S, Wei Y, Zhuo Y, Que S, Jin X, Yao Y, Qian B. Comparing Cognitive Recovery of Remimazolam versus Propofol in Elderly Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Clin Interv Aging 2024; 19:2133-2143. [PMID: 39712634 PMCID: PMC11661974 DOI: 10.2147/cia.s490330] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2024] [Accepted: 12/09/2024] [Indexed: 12/24/2024] Open
Abstract
Background Remimazolam, a novel ultra-short-acting benzodiazepine, shows promise for procedural sedation. This study compared the cognitive recovery of remimazolam versus propofol in elderly patients undergoing colonoscopy. Patients and Methods In this prospective, randomized, double-blind, controlled trial, 228 patients aged ≥ 65 years undergoing outpatient colonoscopies were recruited. Patients received intravenous sufentanil 0.05 μg/kg, followed by either remimazolam 0.2 mg/kg or propofol 1 mg/kg for sedation induction. The assigned study drug (remimazolam 0.1 mg/kg or propofol 0.5 mg/kg) was titrated to maintain a Modified Observer's Assessment of Alertness/Sedation scale score < 3 during the procedure. The primary outcome was the incidence of cognitive recovery, assessed using the Postoperative Quality of Recovery Scale (PostopQRS) cognitive domain on postoperative day 3. Secondary outcomes included overall and other PostopQRS domains recovery, time to discharge, patient satisfaction, and adverse events. Results Cognitive recovery on day 3 was similar between remimazolam (84.2%) and propofol (85.1%) groups (risk ratio = 0.99; 95% CI: 0.89-1.11; p = 0.854). No significant differences were observed in overall recovery, other domains, or discharge time. Remimazolam patients reported higher satisfaction (p = 0.001) and experienced lower incidences of hypotension (21.9% vs 53.5%; p < 0.001), hypoxemia (6.1% vs 16.7%; p = 0.024), and injection site pain (15.8% vs 41.2%; p < 0.001) compared to propofol. Conclusion In elderly patients undergoing colonoscopy, remimazolam demonstrated comparable cognitive recovery to propofol, with higher patient satisfaction and a more favorable safety profile. Remimazolam may be the preferred alternative to propofol for procedural sedation in this vulnerable population. Trial Registration The Chinese Clinical Trial Registry, ChiCTR2200066689.
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Affiliation(s)
- Shuying Lin
- Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China
| | - Ying Wei
- Department of Anesthesiology, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, People’s Republic of China
| | - Yifen Zhuo
- Department of Anesthesiology, Xiamen Haicang Hospital, Xiamen, People’s Republic of China
| | - Shiqin Que
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, People’s Republic of China
| | - Xuepeng Jin
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, People’s Republic of China
| | - Yusheng Yao
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, People’s Republic of China
| | - Bin Qian
- Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, People’s Republic of China
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Yang F, Wang J, Zhang H, Zhang Y, Yang W, Gao R, Yu J, Chen X, Ma H. Effect of Intravenous Lidocaine Infusion on Propofol Dose and Perioperative Pain During Moderate Sedation-Analgesia for Hysteroscopy: A Randomized Controlled Trial. Drug Des Devel Ther 2024; 18:5873-5880. [PMID: 39664966 PMCID: PMC11633289 DOI: 10.2147/dddt.s484486] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/26/2024] [Accepted: 11/30/2024] [Indexed: 12/13/2024] Open
Abstract
Purpose In China, the majority of hysteroscopic procedures require moderate sedation and analgesia. The efficacy of intravenous lidocaine in reducing the need for sedatives and alleviating perioperative pain during hysteroscopy remains equivocal. This study aims to determine whether the intravenous administration of lidocaine can reduce the required dose of propofol and enhance perioperative pain management. Patients and Methods We conducted a prospective, single-center, double-blind randomized controlled trial involving patients with ASA I-II undergoing hysteroscopy. Forty patients were randomly assigned in a 1:1 ratio to either receive an intravenous bolus dose of 1.5 mg/kg lidocaine, followed by a continuous intravenous infusion at 4 mg/kg/h until the conclusion of the procedure, or an equivalent volume of normal saline. Propofol was then titrated to maintain a MOAA/S score of ≤ 2. Results Compared with the control group, the lidocaine group showed a 13.8% decrease in the total dose of propofol (140.0[120.0, 155.0] mg vs 162.5[140.0, 197.5] mg), which was statistically significant (P = 0.014). The induction dose of propofol was 1.37 (1.29, 1.56) mg/kg in the lidocaine group and 1.61 (1.48, 1.94) mg/kg in the control group, respectively (P = 0.001). However, no significant differences were observed between the groups regarding the supplemental dose of propofol (P = 0.062), the number of involuntary movements during hysteroscopy (P = 0.384), or postoperative pain scores (T0: P = 0.628; T1: P = 0.886; T2: P = 0.711). Additionally, the incidence of intraoperative hypoxia (P = 1.000) and fatigue scores (T0: P = 0.878; T1: P = 0.401; T2: P = 0.056) between the two groups were not statistically significant. Conclusion Intravenous lidocaine reduces the dose requirements of propofol during the induction phase of anesthesia. However, it does not have a significant influence on alleviating intraoperative and postoperative pain during hysteroscopic procedures.
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Affiliation(s)
- Fan Yang
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Jie Wang
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
- Department of Anesthesiology, Yan’an Hospital Affiliated to Kunming Medical University, Kunming, 650051, People’s Republic of China
| | - Huiwen Zhang
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Yonghai Zhang
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Wanji Yang
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Ran Gao
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Jingfang Yu
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Xuexin Chen
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
| | - Hanxiang Ma
- Department of Anesthesiology, General Hospital of Ningxia Medical University, Yinchuan, 75004, People’s Republic of China
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Ding G, Wang L, Zhao W, Diao Y, Song D. Comparison of the efficacy and safety of ciprofol and propofol for ERCP anesthesia in older patients: A single-center randomized controlled clinical study. J Clin Anesth 2024; 99:111609. [PMID: 39288685 DOI: 10.1016/j.jclinane.2024.111609] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/14/2024] [Revised: 09/01/2024] [Accepted: 09/05/2024] [Indexed: 09/19/2024]
Abstract
STUDY OBJECTIVES Ciprofol is a novel agonist at the gamma-aminobutyric acid-A (GABAA) receptor, exhibiting better cardiovascular stability and rapid recovery. The objective of this study was to compare the efficacy and safety of ciprofol and propofol for endoscopic retrograde cholangiopancreatography (ERCP) anesthesia in older patients. DESIGN A single-center, randomized, parallel controlled clinical study. SETTING General Hospital of Northern Theater Command. PATIENTS We recruited 284 patients and intended to conduct ERCP from November 2021 to June 2022. INTERVENTIONS Patients scheduled for ERCP were randomly assigned to two groups (n = 142 each): ciprofol group (anesthesia induction 0.3-0.4 mg/kg, anesthesia maintenance 0.8-1.2 mg/kg/h) and propofol group (anesthesia induction 1.5-2.0 mg/kg, anesthesia maintenance 4-12 mg/kg/h). MEASUREMENTS The primary outcome was sedation success rate, defined as the proportion of patients with successful anesthesia induction. Secondary outcomes encompassed the time of successful induction, the time of complete recovery, the time of leaving the room and the incidence rate of adverse events (hypoxemia, hypotension and injection pain). MAIN RESULTS The success rate of sedation in both groups was 100 %. The 95 % CI of the difference of sedation success rate was (- 2.63 %, 2.63 %), and the lower limit was greater than the non-inferiority limit of -8 %.The time of successful sedation induction in ciprofol group (38.4 ± 6.5 s) was longer than that in propofol group (30.6 ± 6.2 s, p < 0.05).The time of complete recovery in ciprofol group (12.8 ± 5.8 min) was shorter than that in propofol group (16.9 ± 5.0 min, p < 0.05). The time of leaving the room in ciprofol group (21.8 ± 5.8 min) was shorter than those in propofol group (25.9 ± 5.1 min, p < 0.05). The incidence of injection pain in ciprofol group (2 %) was lower than that in the propofol group (25 %, p < 0.05). Other outcomes didn't show statistical differences. CONCLUSIONS Compared with propofol, ciprofol exhibited a comparable level of sedation in older patients undergoing ERCP, and recovery was safe and rapid with less injection pain. TRIAL REGISTRATION www.chictr.org.cn (Registration number ChiCTR2100053386, Registration date November 20, 2021).
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Affiliation(s)
- Guopeng Ding
- Department of Anesthesiology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenyang 110016, China; Key Laboratory of Perioperative Critical Care Medicine of Liaoning Province, No.83 Wenhua Road, Shenyang 110016, China
| | - Li Wang
- Department of Anesthesiology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenyang 110016, China; Key Laboratory of Perioperative Critical Care Medicine of Liaoning Province, No.83 Wenhua Road, Shenyang 110016, China
| | - Wantong Zhao
- Anesthesia Surgery Center, Anshan Central Hospital, No.77 South Zhonghua Road, Anshan 114001, China
| | - Yugang Diao
- Department of Anesthesiology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenyang 110016, China; Key Laboratory of Perioperative Critical Care Medicine of Liaoning Province, No.83 Wenhua Road, Shenyang 110016, China
| | - Dandan Song
- Department of Anesthesiology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenyang 110016, China; Key Laboratory of Perioperative Critical Care Medicine of Liaoning Province, No.83 Wenhua Road, Shenyang 110016, China.
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Zhou YH, Li SX, Li L, Deng CM, Shen JJ, Wang DX, Chen XZ, Xu LL. Effect of Remimazolam Supplementation on Propofol Requirements During Hysteroscopy: A Double-Blind, Dose-Response Study. Anesth Analg 2024; 139:1309-1316. [PMID: 38412109 DOI: 10.1213/ane.0000000000006921] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/29/2024]
Abstract
BACKGROUND Propofol is commonly used for procedural sedation but may increase side effects in a dose-dependent manner. Remimazolam, an ultrashort-acting benzodiazepine, has been approved for procedural sedation but may delay awakening. This study tested the hypothesis that remimazolam as a supplement reduces effect-site propofol concentration (Ce prop ) required to suppress response to cervical dilation in patients undergoing hysteroscopy. METHODS One hundred and fifty patients who were scheduled for hysteroscopy were randomized to receive 0, 0.05, 0.1, 0.15, or 0.2 mg·kg -1 intravenous remimazolam, followed by a bolus of sufentanil 0.15 μg⋅kg -1 , and a target-controlled propofol infusion. The initial target Ce prop was 3.5 μg·mL -1 and was increased or decreased in subsequent patients by steps of 0.5 μg·mL -1 according to whether there was loss of response to cervical dilation in the previous patient. We used up-down sequential analysis to determine values of Ce prop that suppressed response to cervical dilation in 50% of patients (EC 50 ). RESULTS The EC 50 of propofol for suppressing response to cervical dilation was lower in patients given 0.1 mg·kg -1 (2.08 [95% confidence interval, CI, 1.88-2.28] μg·mL -1 ), 0.15 mg⋅kg -1 (1.83 [1.56-2.10] μg·mL -1 ), and 0.2 mg⋅kg -1 (1.43 [1.27-1.58] μg·mL -1 ) remimazolam than those given 0 mg⋅kg -1 (3.67 [3.49-3.86] μg·mL -1 ) or 0.05 mg⋅kg -1 (3.47 [3.28-3.67] μg·mL -1 ) remimazolam (all were P < .005). Remimazolam at doses of 0.1, 0.15, and 0.2 mg·kg -1 decreased EC 50 of propofol by 43.3% (95% CI, 41.3%-45.5%), 50.3% (48.0%-52.8%), and 61.2% (58.7%-63.8%), respectively, from baseline (remimazolam 0 mg⋅kg -1 ). Propofol consumption was lower in patients given 0.1 mg⋅kg -1 (4.15 [3.51-5.44] mg·kg -1 ), 0.15 mg⋅kg -1 (3.54 [3.16-4.46] mg·kg -1 ), and 0.2 mg⋅kg -1 (2.74 [1.73-4.01] mg·kg -1 ) remimazolam than those given 0 mg⋅kg -1 (6.09 [4.99-7.35] mg·kg -1 ) remimazolam (all were P < .005). Time to anesthesia emergence did not differ significantly among the 5 groups. CONCLUSIONS For women undergoing hysteroscopic procedures, remimazolam at doses from 0.1 to 0.2 mg·kg -1 reduced the EC 50 of propofol inhibiting response to cervical dilation and the total propofol requirement. Whether the combination could improve perioperative outcomes deserves further investigation.
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Affiliation(s)
- Yan-Hong Zhou
- From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Shu-Xi Li
- From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Lin Li
- From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
- Department of Anesthesia, Haiyan People's Hospital, Jiaxing, Zhejiang Province, China
| | - Chun-Mei Deng
- Department of Anesthesia, Peking University First Hospital, Beijing, China
| | - Jian-Jun Shen
- Department of Anesthesia, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Dong-Xin Wang
- Department of Anesthesia, Peking University First Hospital, Beijing, China
| | - Xin-Zhong Chen
- From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
| | - Li-Li Xu
- From the Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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Bui A, Serafin J, Shah S, Barnett KM. Hemodynamic Stability of Midazolam versus Remimazolam During Outpatient Genitourinary Interventional Radiology Procedures in a Patient With Aortic Stenosis: A Case Report. A A Pract 2024; 18:e01879. [PMID: 39655835 PMCID: PMC11636967 DOI: 10.1213/xaa.0000000000001879] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2024]
Abstract
Patients with aortic stenosis (AS) and other significant cardiopulmonary comorbidities are vulnerable to hemodynamic instability during anesthesia. This case report compares the use of remimazolam and midazolam in a 71-year-old man with symptomatic AS, chronic kidney disease, and ischemic cardiomyopathy. The patient underwent multiple short ambulatory interventional radiology procedures. While moderate sedation with midazolam resulted in significant hypotension, use of remimazolam in subsequent procedures demonstrated a stable hemodynamic profile despite increased disease burden. This report highlights the potential advantages of remimazolam compared to midazolam in high-risk patients undergoing interventional radiology procedures.
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Affiliation(s)
- Anastasia Bui
- From the SUNY Downstate College of Medicine, Brooklyn, New York
| | - Joanna Serafin
- Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, New York
| | - Suken Shah
- Department of Anesthesiology and Critical Care Medicine, MSK Monmouth, Memorial Sloan Kettering Cancer Center, Middletown, New Jersey
| | - Kara M Barnett
- Department of Anesthesiology and Critical Care Medicine, MSK Monmouth, Memorial Sloan Kettering Cancer Center, Middletown, New Jersey
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He KQ, Huang TT, Tan MY, Gao C, Wang S. Efficacy and Safety of Ciprofol Versus Propofol as Anesthetic for Patients Undergoing Painless Colonoscopy. Pain Ther 2024; 13:1633-1644. [PMID: 39400664 PMCID: PMC11543975 DOI: 10.1007/s40122-024-00662-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/04/2024] [Accepted: 09/19/2024] [Indexed: 10/15/2024] Open
Abstract
INTRODUCTION Ciprofol is a novel propofol analogue with a characteristic of hemodynamic stability. At present, there is a lack of research comparing the hemodynamic stability of ciprofol and propofol during painless colonoscopy. In this study, we aim to test the hypothesis that ciprofol is superior to propofol in terms of hemodynamic stability for sedation anesthesia in patients undergoing colonoscopy. METHODS A total of 222 patients were randomized into two groups. Patients in group P (n = 112) and group C (n = 110) received propofol and ciprofol sedation, respectively. Noninvasive blood pressure were monitored starting from induction (T0) to the end of the procedure, at 2-min intervals (T1 to T10). Heart rate variability (HRV), pain injection, Modified Observer's Assessment of Alertness and Sedation (MOAA/S) score, body movement, doses of norepinephrine, modified Aldrete score, drug-related adverse reactions, and patient satisfaction and endoscopist satisfaction were recorded. RESULTS In group C, fewer patients experienced a decrease in blood pressure with a higher HRV after induction sedation, the incidence of pain injection was reduced, the amount of norepinephrine dose was decreased, patient satisfaction was increased compared with group P (all P < 0.05). There were no significant differences in induction time, modified Aldrete score, alertness time, drug-related adverse reactions, and endoscopist satisfaction. CONCLUSIONS Our study indicated intravenous induction with ciprofol was superior, with regard to hemodynamic stability and reduced injection pain, than induction with propofol for anesthesia in patients undergoing painless colonoscopy. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR2200061814).
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Affiliation(s)
- Ke Qiang He
- Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, P.R. China
| | - Ting Ting Huang
- Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230011, China
- Anhui Public Health Clinical Center, Hefei, 230011, China
| | - Meng Yuan Tan
- Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, P.R. China
| | - Chen Gao
- Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, P.R. China.
| | - Sheng Wang
- Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, 230001, P.R. China.
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Lu D, Zeng Q, Zhang A, Wei W, Huang H, Chen W, Li J, Yao Y, Gu Y. Effect of remimazolam besylate versus propofol on haemodynamic profiles in patients undergoing thyroid surgery with recurrent laryngeal nerve monitoring: a protocol for a randomised controlled trial. BMJ Open 2024; 14:e089650. [PMID: 39578027 PMCID: PMC11590782 DOI: 10.1136/bmjopen-2024-089650] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/10/2024] [Accepted: 10/24/2024] [Indexed: 11/24/2024] Open
Abstract
INTRODUCTION Thyroid surgery with intraoperative nerve monitoring under total intravenous anaesthesia often requires deeper sedation due to limitations or lack of neuromuscular blocking agents, usually resulting in haemodynamic instability. Remimazolam, a newly developed sedative, is being studied for its effect on the haemodynamic profile of patients undergoing this procedure and compared with propofol. METHODS AND ANALYSIS This will be a single-centre, single-blind, randomised, controlled trial in American Society of Anesthesiologists I-III patients between the ages of 18 and 65 who require recurrent laryngeal nerve monitoring for thyroid surgery. Patients will be randomised 1:1 to either remimazolam besylate or propofol, with 142 cases in each group according to a randomised, computer-generated cohort. The primary outcome is the occurrence of hypotension from induction of anaesthesia to full recovery. Secondary outcomes include the administration of vasoactive agents, the number of hypotension or hypertension episodes, the cumulative duration of hypotension or hypertension, the dose of intraoperative rescue sedation and analgesia, the time to extubation and awakening and the incidence of adverse events. ETHICS AND DISSEMINATION Ethical approval for this study was obtained from the Medical Ethics Committee of the Affiliated Cancer Hospital and Institute of Guangzhou Medical University (2023-2024). The study protocol was modified according to the reviewers' comments, and the revised version was approved by the Ethics Committee (2024 Research Ethics Amendment No. 3). On completion of the study, we will commit to ensuring that the results are made available to the public, regardless of the outcome. This will include either publication in an appropriate journal or oral presentation at academic conferences. TRIAL REGISTRATION NUMBER ChiCTR2300076583.
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Affiliation(s)
- Dianyu Lu
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Qingmei Zeng
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Anyu Zhang
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Wei Wei
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Haiyan Huang
- Department of Head and Neck Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Weiquan Chen
- Department of Head and Neck Surgery, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Jinfei Li
- Department of Anaesthesiology, Guangdong Women and Children Hospital, Guangzhou, Guangdong, China
| | - Yonghua Yao
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
| | - Yu Gu
- Department of Anaesthesiology, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong, China
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Deng BR, Zhang Y, Xie ZF, Wang DD, Zeng T, Zhang DB, Huang L, Wang QY, Shen T, Wu QL. Comparative Analysis of Hemodynamic Effects of Remimazolam and Propofol Combined with Esketamine in Colonoscopic Procedures in the Elderly. Drug Des Devel Ther 2024; 18:5269-5280. [PMID: 39588393 PMCID: PMC11586265 DOI: 10.2147/dddt.s490179] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Accepted: 11/05/2024] [Indexed: 11/27/2024] Open
Abstract
Purpose The debate continues over the differential impact of remimazolam vs propofol on hemodynamic stability. This study aims to elucidate the effects of a combination of remimazolam and esketamine vs propofol and esketamine on hemodynamic parameters in elderly patients undergoing painless colonoscopies. Patients and Methods We conducted a randomized controlled trial involving 754 patients, divided equally between two treatment groups. The remimazolam-esketamine group (RE group) received 0.15 mg/kg of remimazolam and 0.3 mg/kg of esketamine. Conversely, the propofol-esketamine group (PE group) was administered 1.5 mg/kg of propofol with 0.3 mg/kg of esketamine. Primary outcomes focused on the incidence of hypotension. Secondary outcomes assessed were other hemodynamic adverse events, intraoperative blood pressure and heart rate fluctuations, usage of vasoactive agents, sedation efficacy, and additional adverse reactions. Results Hypotension occurred significantly less frequently in the RE group (9.78%, 95% confidence interval[CI]: 6.67-12.87%) compared to the PE group (23.57%, 95% CI: 21.22-30.52%), P<0.001. The RE group also showed lower incidences of sinus tachycardia, sinus bradycardia, and required less support from vasoactive agents (P<0.001). Additionally, the RE group experienced smaller fluctuations in blood pressure and heart rate (P<0.05). Both groups achieved a 100% sedation success rate. Notably, the RE group had a longer induction period but a quicker recovery time (P<0.001), and lower rates of respiratory depression (P=0.006) and injection pain (P<0.001). Conclusion Remimazolam combined with esketamine offers superior hemodynamic stability and significantly reduces adverse event rates compared to propofol plus esketamine in elderly patients undergoing painless colonoscopies, while maintaining effective sedation.
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Affiliation(s)
- Bo-Ran Deng
- Surgical Anesthesia Center, Zigong Hospital of TCM, Zigong, 643000, People’s Republic of China
| | - Yang Zhang
- Department of Anesthesia, Da’an District Maternal and Child Health Hospital, Zigong, 643000, People’s Republic of China
| | - Zi-Feng Xie
- Department of Anesthesia, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, 121000, People’s Republic of China
| | - Ding-Ding Wang
- Department of Anesthesia, EYE & ENT Hospital of Fudan University, Shanghai, 200031, People’s Republic of China
| | - Tao Zeng
- Surgical Anesthesia Center, Zigong Hospital of TCM, Zigong, 643000, People’s Republic of China
| | - Dong-Bo Zhang
- Department of Anesthesia, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, 121000, People’s Republic of China
| | - Li Huang
- Surgical Anesthesia Center, Zigong Hospital of TCM, Zigong, 643000, People’s Republic of China
| | - Qi-Yan Wang
- Surgical Anesthesia Center, Zigong Hospital of TCM, Zigong, 643000, People’s Republic of China
| | - Tu Shen
- Department of Anesthesia, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, 121000, People’s Republic of China
| | - Qiao-Ling Wu
- Department of Anesthesia, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, 121000, People’s Republic of China
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Liu Y, Zuo L, Li X, Nie Y, Chen C, Liu N, Chen M, Wu J, Guan X. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care 2024; 14:164. [PMID: 39455495 PMCID: PMC11511798 DOI: 10.1186/s13613-024-01390-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/24/2024] [Accepted: 10/07/2024] [Indexed: 10/28/2024] Open
Abstract
BACKGROUND Ciprofol was approved for use in intensive care unit (ICU) patients requiring sedation during mechanical ventilation in July 2022. A pooled post-hoc analysis of phase 2 and phase 3 trials was conducted primarily to explore hypotension-free outcome in ICU patients who required mechanical ventilation and achieved the target light sedation goal at an early stage after being sedated with ciprofol or propofol. METHODS All eligible ICU patients who were expected to require sedation for 6-24 h were randomly assigned in a 2:1 ratio to either a ciprofol or propofol group. Ciprofol or propofol was initially infused at loading doses of 0.5 or 1.0 mg/kg followed by maintenance doses of 0.3 or 1.5 mg/kg/h. Ciprofol or propofol dosages were adjusted up or down at rates of 0.05-0.10 mg/kg/h or 0.25-0.50 mg/kg/h, respectively, to achieve the target light sedation (a Richmond Agitation-Sedation Scale of -2 to + 1). The primary post-hoc outcome was the hypotension-free rate in patients who had achieved the target sedation goal after 30-min administration of ciprofol or propofol. RESULTS In total, 174 patients were enrolled for pooled post-hoc analysis, of whom 116 and 58 were assigned to the ciprofol and propofol groups, respectively. The hypotension-free rate was significantly higher in patients who achieved the target sedation goal after 30-min administration of ciprofol (93.0% vs. 81.0%, P = 0.018), and especially in the subgroups of males and patients aged < 65 years. Multivariable analysis revealed that ciprofol treatment, a younger age and lower baseline body mass index were independent favorable predictors for a higher hypotension-free rate in patients who achieved the target sedation goal after 30-min of drug administration. Moreover, hypotension-free patients who reached the target sedation level after 30 min had a more favorable short-term prognosis including a lower incidence of drug-related treatment-emergent adverse events, shorter time to extubation and fewer dose adjustments of ciprofol or propofol (all P < 0.05). CONCLUSION ICU patients undergoing mechanical ventilation and sedated with ciprofol had significantly lower rate of hypotension during the early phase of achieving light sedation during a 6-24 h period, leading to a more favorable short-term prognosis (within 24 h). TRIAL REGISTRATION Phase 2 trial (clinicaltrials.gov, NCT04147416. Registered November 1, 2019, https://classic. CLINICALTRIALS gov/ct2/show/NCT04147416 ) and phase 3 trial (clinicaltrials.gov, NCT04620031. Registered November 6, 2020, https://classic. CLINICALTRIALS gov/ct2/show/NCT04620031 ).
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Affiliation(s)
- Yongjun Liu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Lingyun Zuo
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Xiaoyun Li
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Yao Nie
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Chuanxi Chen
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Ning Liu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Minying Chen
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Jianfeng Wu
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China
| | - Xiangdong Guan
- Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, 510080, China.
- Guangdong Clinical Research Center for Critical Care Medicine, No. 58 Zhongshan 2nd Road, Guangzhou, 510080, China.
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Zhou B, Li S, Luo A, Zheng H. The efficacy and safety of remimazolam tosilate compared with propofol for endoscopic retrograde cholangiopancreatography under monitored anesthesia care: A single-center randomized controlled clinical trial. Heliyon 2024; 10:e38349. [PMID: 39391505 PMCID: PMC11466613 DOI: 10.1016/j.heliyon.2024.e38349] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2024] [Revised: 09/19/2024] [Accepted: 09/23/2024] [Indexed: 10/12/2024] Open
Abstract
Background Although remimazolam tosilate is an ultra-short-acting benzodiazepine that causes less respiratory and circulatory depression than propofol, studies evaluating its efficacy and safety during endoscopic retrograde cholangiopancreatography (ERCP) are limited. This study aimed to compare the efficacy and safety of remimazolam and propofol for ERCP performed under monitored anesthesia care (MAC). Methods This study is a randomized controlled clinical trial featuring a noninferiority design. A total of 102 eligible patients undergoing ERCP under MAC were randomly assigned to either the remimazolam tosilate group (R group) or the propofol group (P group) in a 1:1 ratio. Patients in the R group were sedated with remimazolam tosilate, while those in the P group received propofol, both under MAC. The primary efficacy endpoint was the success rate of ERCP completion under MAC. Secondary outcomes included the time to loss of consciousness, sedative effects, and perioperative adverse events at various time points for patients in both groups. Results Baseline characteristics of both groups were similar. The successful completion rate for ERCP under MAC was 100 % in the R group and 96.1 % in the P group, resulting in a difference of 3.92 % (95 % CI: -2%, 10 %). This difference met the pre-established criterion of being greater than -8%. The total number of norepinephrine infusions, as well as the incidence of intravenous injection pain, post-induction hypotension, post-induction bradycardia, intraoperative hypotension, respiratory depression, and hypoxemia, were significantly lower in the R group compared to the P group. Conversely, the total number of phloroglucinol uses, body movements, and instances of rapid gastrointestinal peristalsis were significantly higher in the R group than in the P group. Discussion Remimazolam-based MAC for ERCP exhibited non-inferior efficacy compared to propofol-based MAC, while also resulting in fewer circulatory and respiratory adverse events during the procedures. Nevertheless, future studies with larger sample sizes are required to evaluate the utility of remimazolam in elderly patients.
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Affiliation(s)
- Biyun Zhou
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Shiyong Li
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ailin Luo
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Hongbo Zheng
- Department of Anesthesiology and Pain Medicine, Hubei Key Laboratory of Geriatric Anesthesia and Perioperative Brain Health, and Wuhan Clinical Research Center for Geriatric Anesthesia, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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Luo X, Hou HJ, Chen PS, Chang XL, Li Y, An LX, Liu FK, Xue FS. Addition of Dexmedetomidine to the Anesthesia Regimen Attenuates Pain and Improves Early Recovery After Esophageal Endoscopic Submucosal Dissection: A Randomized Controlled Trial. Drug Des Devel Ther 2024; 18:4551-4562. [PMID: 39411154 PMCID: PMC11476426 DOI: 10.2147/dddt.s475749] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/26/2024] [Accepted: 10/07/2024] [Indexed: 10/19/2024] Open
Abstract
Objective Postoperative pain is a common yet often underestimated complication following esophageal endoscopic submucosal dissection (ESD), with limited strategies for effective management. This prospective, double-blind, randomized controlled trial assessed the effects of adding dexmedetomidine (DEX) to the anesthesia regimen on postoperative pain and early recovery in patients undergoing esophageal ESD. Methods In total, 60 patients scheduled for elective esophageal ESD under general anesthesia were randomly assigned to the DEX or control group. The DEX group received an intravenous loading dose of DEX at 1 μg/kg for 10 min, followed by a continuous intravenous infusion of 0.6 µg/kg/h, which was stopped 30 min before the end of the procedure. The control group received normal saline as a placebo. The study's primary outcome was the incidence of moderate-to-severe postoperative pain. Secondary outcomes included postoperative pain scores, hemodynamic parameters, the occurrence of postoperative nausea and vomiting (PONV), patient satisfaction, and lengths of stay in the post-anesthesia care unit (PACU) and hospital. Results The incidence of moderate-to-severe postoperative pain in the DEX group was significantly lower than that in the control group (absolute difference: -33.4%; OR: 0.250; 95% CI: 0.085-0.731, P = 0.01). Pain scores at 1 h postoperatively (0.5[2.0] vs 3.0[1.3], P = 0.003) were significantly lower in the DEX group. Additionally, morphine dosage in the PACU (0[0] vs 1.0[2.0] P = 0.004) was significantly reduced in the DEX group compared with the control group. In the DEX group, the incidence and severity of PONV were significantly decreased and the length of PACU stay was shorter than in the control group (P < 0.01). However, the rates of intraoperative hypotension, tachycardia, and bradycardia were similar between the two groups. Patient satisfaction and length of hospital stay were also comparable. Conclusion Adding DEX to the anesthesia regimen for esophageal ESD significantly attenuates postoperative pain and improves early recovery outcomes.
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Affiliation(s)
- Xin Luo
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Hai-Jun Hou
- Department of Pain Medicine, Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, People’s Republic of China
| | - Pei-Shan Chen
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Xin-Lu Chang
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Yang Li
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Li-Xin An
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Fu-Kun Liu
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
| | - Fu-Shan Xue
- Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China
- Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, Fuzhou, People’s Republic of China
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Tan H, Lou A, Wu J, Chen X, Qian X. Comparison of hypotension between propofol and remimazolam-propofol combinations sedation for day-surgery hysteroscopy: a prospective, randomized, controlled trial. BMC Anesthesiol 2024; 24:360. [PMID: 39379858 PMCID: PMC11460140 DOI: 10.1186/s12871-024-02746-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2024] [Accepted: 09/26/2024] [Indexed: 10/10/2024] Open
Abstract
BACKGROUND A combination of remimazolam and propofol could produce more stable sedation. A good medication regimen should consider not only efficacy but also safety, especially hypotension. The aim of the current study was to compare the incidence and amount of hypotension by propofol versus remimazolam-propofol combinations in day-surgery hysteroscopy. METHODS Patients were randomly assigned to receive either propofol (Group P, n = 125) or remimazolam-propofol combinations (Group RP, n = 125) at a 1:1 ratio. Intravenous injection of sufentanil 0.1ug/kg were administered before sedative medication. In group P, a bolus of 2.5 mg/kg propofol was administered. In group RP, intravenous anesthesia was commenced with 0.125 mg/kg remimazolam and 1 mg/kg propofol. After loss of consciousness, propofol was maintained at 6 mg/kg/h. The primary outcomes were the incidence and amount of hypotension during surgery. Hypotension was defined as a MAP less than 65mmHg for at least 1 min. The amount of hypotension was assessed by time-weighted average intraoperative MAP under a threshold of 65 mmHg. The secondary outcomes were various anesthesia related parameters and some adverse events. RESULTS In group P, 25 patients (20.0%) experienced hypotension during hysteroscopy compared with 9 patients (7.2%) in group RP, for a difference of 12.8% (RR 2.778, 95%CI [1.352-5.709]). The combination of remimazolam and propofol resulted in significantly lower TWA (Time Weighted Average) threshold 0.14 (0.10-0.56) mmHg in group RP compared to 0.31 (0.15-0.67) mmHg in group P. The total dose of propofol was nearly double in group P compared to group RP. A significantly higher frequency of injection pain and low oxygen saturation was observed in the group P than that of the group RP. Hiccup was observed only in group RP. The incidences of body movement, bradycardia and vomiting were no significant difference between groups. CONCLUSION The incidence and amount of hypotension by remimazolam-propofol combinations was significantly less than that by propofol sedation in day-surgery hysteroscopy. The optimization of medication regimen would attenuate the harm of hypotension and contribute to patients' rapid recovery in day surgery. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR2400079888 (date: 15/01/2024).
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Affiliation(s)
- Hua Tan
- Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China
| | - Aifei Lou
- Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China
| | - Jianer Wu
- Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China
| | - Xinzhong Chen
- Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
| | - Xiaowei Qian
- Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People's Republic of China.
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Kim JH, Nam JS, Seo WW, Joung KW, Chin JH, Kim WJ, Choi DK, Choi IC. Effects of remimazolam versus dexmedetomidine on recovery after transcatheter aortic valve replacement under monitored anesthesia care: a propensity score-matched, non-inferiority study. Korean J Anesthesiol 2024; 77:537-545. [PMID: 39039823 PMCID: PMC11467503 DOI: 10.4097/kja.24138] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Revised: 06/15/2024] [Accepted: 07/05/2024] [Indexed: 07/24/2024] Open
Abstract
BACKGROUND Minimalist transcatheter aortic valve replacement (TAVR) under monitored anesthesia care (MAC) emphasizes early recovery. Remimazolam is a novel benzodiazepine with a short recovery time. This study hypothesized that remimazolam is non-inferior to dexmedetomidine in terms of recovery after TAVR. METHODS In this retrospective observational study, remimazolam was compared to dexmedetomidine in patients who underwent TAVR under MAC at a tertiary academic hospital between July 2020 and July 2022. The primary outcome was timely recovery after TAVR, defined as discharge from the intensive care unit within the first day following the procedure. Propensity score matching was used to compare timely recovery between remimazolam and dexmedetomidine, applying a non-inferiority margin of -10%. RESULTS The study included 464 patients, of whom 218 received remimazolam and 246 received dexmedetomidine. After propensity score matching, 164 patients in each group were included in the analysis. Regarding timely recovery after TAVR, remimazolam was non-inferior to dexmedetomidine (152 of 164 [92.7%] in the remimazolam group versus 153 of 164 [93.3%] in the dexmedetomidine group, risk difference [95% CI]: -0.6% [-6.7%, 5.5%]). The use of remimazolam was associated with fewer postoperative vasopressors/inotropes (21 of 164 [12.8%] vs. 39 of 164 [23.8%]) and temporary pacemakers (TPMs) (76 of 164 [46.3%] vs. 108 of 164 [65.9%]) compared to dexmedetomidine. CONCLUSIONS In patients undergoing TAVR under MAC, remimazolam was non-inferior to dexmedetomidine in terms of timely recovery. Remimazolam may be associated with better postoperative recovery profiles, including a lesser need for vasopressors/inotropes and TPMs.
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Affiliation(s)
- Ji-Hyeon Kim
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Jae-Sik Nam
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Wan-Woo Seo
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Kyung-Woon Joung
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Ji-Hyun Chin
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Wook-Jong Kim
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - Dae-Kee Choi
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
| | - In-Cheol Choi
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
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Lu L, Chen B, Zhao X, Zhai J, Zhang P, Hua Z. Comparison of Remimazolam and Propofol in Recovery of Elderly Outpatients Undergoing Gastrointestinal Endoscopy: A Randomized, Non-Inferiority Trial. Drug Des Devel Ther 2024; 18:4307-4318. [PMID: 39359483 PMCID: PMC11446194 DOI: 10.2147/dddt.s474275] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/20/2024] [Accepted: 09/11/2024] [Indexed: 10/04/2024] Open
Abstract
Purpose We designed this trial to compare the recovery time of remimazolam and propofol in elderly patients undergoing painless gastrointestinal endoscopy. Patients and Methods In this randomized, non-Inferiority trial, 360 patients aged 65 years or older, scheduled for elective outpatient gastrointestinal endoscopy, were randomly assigned to the remimazolam combined with fentanyl (RF) group or the propofol combined with fentanyl (PF) group. The primary outcome was the post-anesthesia care unit (PACU) stay time, defined as the time from the end of the examination to scoring 9 points using the Modified Post-Anesthetic Discharge Scoring System (MPADSS) criteria. Secondary outcomes included sedation-related adverse events, recall, injection pain, as well as postoperative Quality of Recovery-15 (QoR-15) scores and Pittsburgh Sleep Quality Index (PSQI) scores at 1 day, 1 week, and 1 month postoperatively. Results A total of 351 patients completed the study, with 174 receiving remimazolam and 177 receiving propofol. The PACU stay time in RF group was non-inferior to that in PF group [14 (11, 18) vs 13 (10, 17), mean difference 1 (95% confidence interval 0, 2), P=0.084 for noninferiority]. However, remimazolam was associated with lower rate of hypoxemia [4.7% (8/180) vs 12.4% (22/180), P=0.011], reduced use of vasoactive drugs [1 (0, 1) vs 1 (1, 2), P<0.001], less injection pain [2 (1.2%) vs 35 (21.3%), P<0.001], and lower recall [20 (11.8%) vs 36 (20.3%), P=0.034]. There were no differences in the QoR-15 scores and PSQI scores at postoperative 1 day, 1 week, and 1 month between groups. Conclusion This non-inferiority study revealed that in elderly outpatients undergoing gastrointestinal endoscopy, remimazolam achieved recovery times comparable to propofol, with fewer associated complications.
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Affiliation(s)
- Lin Lu
- Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Bing Chen
- Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Xueli Zhao
- Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Jie Zhai
- Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Pan Zhang
- Department of Gastroenterology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
| | - Zhen Hua
- Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
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Fu M, Sheng B, Liu R, Li Y, Chen G, Chen H, Chen X, Duan G, Huang H, Chen J, Chen Y. Impact of different doses of esketamine on the incidence of hypotension in propofol-based sedation for colonoscopy: a randomized controlled trial. Ther Adv Drug Saf 2024; 15:20420986241278499. [PMID: 39314988 PMCID: PMC11418320 DOI: 10.1177/20420986241278499] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Accepted: 08/08/2024] [Indexed: 09/25/2024] Open
Abstract
Background Hypovolemia is common in colonoscopy due to fasting and bowel preparation, and propofol itself can reduce systemic vascular resistance, resulting in relative hypovolemia. Therefore, hypotension is not a rare event during propofol-based sedation for colonoscopy. Objectives Our objective was to explore the efficacy of esketamine as a sedative adjuvant in reducing the incidence of hypotension during colonoscopy. Design This was a prospective randomized trial. The trial was registered with the Chinese Clinical Trial Registry (ID: ChiCTR 2100047032). Methods We included 100 eligible patients who planned to receive a colonoscopy and randomly divided them into 4 groups with 25 patients in each group, which were propofol 2 mg/kg (Group P), propofol 1 mg/kg with esketamine 0.2 mg/kg (Group E1), propofol 1 mg/kg with esketamine 0.3 mg/kg (Group E2), and propofol 1 mg/kg with esketamine 0.4 mg/kg (Group E3). The hemodynamic and respiratory parameters were documented at various times during the procedure, including the patient's entry into the endoscopic room (T0), the induction of sedation (T1), the insertion of the colonoscope (T2), the removal of the colonoscope (T3), and the awakening of the patient (T4). The primary outcome was the incidence of hypotension. Secondary outcomes were cardiovascular side effects other than hypotension, incidence of hypoxia, cumulative changes in cardiovascular and respiratory parameters, total propofol dosage, anesthesia recovery time, and satisfactory levels of both patients and endoscopists. Results The incidence of hypotension in Group E1 (16%), Group E2 (16%), and Group E3 (12%) was significantly lower than in Group P (60%), with p values 0.003, 0.003, and <0.001 respectively. The cumulative changes in diastolic blood pressure and mean arterial pressure in Groups E1, E2, and E3 were significantly higher than in Group P (p = 0.024, p < 0.001, p = 0.006, respectively). Cumulative changes in systolic blood pressure in Group E3 were significantly higher than those in Group P (p = 0.012). The respiratory-related parameters were not statistically significant. Conclusions This study showed that the application of 0.4 mg/kg esketamine in propofol-based sedation reduced the incidence of hypotension during colonoscopy while providing satisfactory sedation.
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Affiliation(s)
- Mengyue Fu
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Bo Sheng
- Department of Gastroenterology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Rui Liu
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Yongjie Li
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Guizhen Chen
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Hai Chen
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Xuehan Chen
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Guangyou Duan
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - He Huang
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China
| | - Jie Chen
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing 400010, China
| | - Yuanjing Chen
- Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing 400010, China
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Hamdaoui A, Turki H, Lassoued T, Samet A, Rejeb I. Managing scorpion envenomations: A Gabes emergency department case study of 60 patients. LA TUNISIE MEDICALE 2024; 102:529-536. [PMID: 39287344 PMCID: PMC11450744 DOI: 10.62438/tunismed.v102i9.4885] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 02/25/2024] [Accepted: 06/17/2024] [Indexed: 09/19/2024]
Abstract
INTRODUCTION Scorpion envenomation constitutes a major public health issue in Tunisia, especially in arid regions such as the Gulf of Gabes. It is necessary to understand the epidemiological and clinical characteristics of this condition and the importance of early management. AIM This study aims to assess the epidemiological and clinical profile of patients admitted to the emergency department of Gabes University Hospital for scorpion envenomation, as well as the timing of management and intra-hospital evolution. METHODS A retrospective descriptive study of 60 patients admitted for scorpion envenomation to the Acute Assessement unit at the Emergency Department of the Gabes University Hospital from January 2020 to January 2023. RESULTS The average age was 35 years [1-85 years]. A slight male predominance (51.7%) was noted. Patients with chronic somatic diseases accounted for (25%) of our series. The predominant scorpion species was Androctonus australis (71.7%). The majority of incidents occurred during the nighttime (71.7%). Most patients were of rural origin (58.3%). The most common sting sites were the lower limbs (48.8%) and upper limbs (36.7%). Scorpion envenomation stages at admission were: Stage I (3.3%), Stage II (83.3%), and Stage III (8.33%). The average time to management was 2 hours. Patients classified as Stage II at admission or afterward were seen after an average of 3 hours. Patients initially classified as Stage III were seen after an average of 3 hours and 30 minutes, and those classified as Stage III during the hospitalization were seen after an average of 4 hours. The average time to management for patients transferred from the Emergency Department to the Intensive Care Unit was 4 hours. CONCLUSION This study highlights the importance of early management of scorpion envenomation.
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Affiliation(s)
- Amine Hamdaoui
- Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia
- Emergency Department, University Hospital of Gabes, Gabes, Tunisia
| | - Houcemeddine Turki
- Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia
- Data Engineering and Semantics Research Unit, University of Sfax, Sfax, Tunisia
| | - Taha Lassoued
- Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia
| | - Amal Samet
- Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia
- Emergency Department, University Hospital of Gabes, Gabes, Tunisia
| | - Imen Rejeb
- Faculty of Medicine of Sfax, University of Sfax, Sfax, Tunisia
- Emergency Department, University Hospital of Gabes, Gabes, Tunisia
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Lu YF, Wu JM, Lan HY, Xu QM, Shi SQ, Duan GC. Efficacy and Safety of General Anesthesia Induction with Ciprofol in Hip Fracture Surgery of Elderly Patients: A Randomized Controlled Trial. Drug Des Devel Ther 2024; 18:3951-3958. [PMID: 39247794 PMCID: PMC11380857 DOI: 10.2147/dddt.s475176] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/23/2024] [Accepted: 09/01/2024] [Indexed: 09/10/2024] Open
Abstract
Background Ciprofol is a new intravenous sedative / anesthetic drug. In recent years, many clinical studies have also confirmed the sedative effect of ciprofol. However, more clinical research is still needed on its clinical application characteristics in special populations. Objective The aim of this study was to compare the clinical effects of ciprofol and propofol in general anesthesia induction of elderly patients. Methods 60 elderly (aged ≥ 75 years) patients underwent hip fracture surgery were randomly into two groups of a 1:1 ratio. Group C (ciprofol group): 0.3mg/kg ciprofol was infused. Group P (propofol group): 1.5mg/kg propofol was infused. The observation period was from the infusion of test drug to 5 min after endotracheal intubation. The primary outcomes included the incidence of severe hypotension and hypotension during the observation period. The secondary outcomes were as follows: the success rate of general anesthesia induction, the number of additional sedation, the time of loss of consciousness (LOC), Δ MAP, Δ HR, adverse events and the frequency of vasoactive drugs used. Results Finally, 60 subjects completed the study. Compared with Group P, the incidence of severe hypotension in Group C was lower (26.7% vs 53.3%, P = 0.035), the incidence of hypotension was also lower (36.7% vs 63.3%, P = 0.037), Δ MAP in Group C was significantly lower (31.4 ± 11.4 vs 39.6 ± 15.7, P = 0.025), the frequency of ephedrine used and the incidence of injection pain in Group C were also significantly lower. Conclusion Ciprofol showed similar efficacy to propofol when used for general anesthesia induction in elderly patients underwent hip fracture surgery and could maintain more stable blood pressure.
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Affiliation(s)
- Yan-fei Lu
- Center for Rehabilitation Medicine, Department of Anesthesiology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, People’s Republic of China
| | - Ji-min Wu
- Department of Anesthesiology, Lishui People’s Hospital, Wenzhou Medical University Lishui Hospital, Lishui, People’s Republic of China
| | - Hai-yan Lan
- Department of Anesthesiology, Lishui People’s Hospital, Wenzhou Medical University Lishui Hospital, Lishui, People’s Republic of China
| | - Qiao-min Xu
- Department of Anesthesiology, Lishui People’s Hospital, Wenzhou Medical University Lishui Hospital, Lishui, People’s Republic of China
| | - Shu-qi Shi
- Department of Anesthesiology, Lishui People’s Hospital, Wenzhou Medical University Lishui Hospital, Lishui, People’s Republic of China
| | - Gong-chen Duan
- Department of Anesthesiology, Lishui People’s Hospital, Wenzhou Medical University Lishui Hospital, Lishui, People’s Republic of China
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Lin J, Cai Z, Lin Y, Wu H, Gu Y. Efficacy of Low-Dose Scopolamine and Palonosetron in Reducing Immediate Post-Gastrointestinal Endoscopy Nausea and Vomiting: A Prospective, Randomized, Controlled Study. J Clin Pharmacol 2024. [PMID: 39223994 DOI: 10.1002/jcph.6127] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/24/2024] [Accepted: 08/19/2024] [Indexed: 09/04/2024]
Abstract
This study aimed to assess the incidence of post-discharge nausea and vomiting (PDNV) following sedation with nalbuphine and etomidate and to evaluate the prophylactic effects of scopolamine in reducing PDNV. A two-stage prospective clinical trial was conducted. The first part involved an observational study of 77 subjects to assess the PDNV incidence post-sedation with nalbuphine, etomidate, and propofol. The second part compared the effectiveness of palonosetron 0.075 mg (P group), scopolamine 0.1 mg (S group), and their combination (PS group) in reducing PDNV. The primary endpoint was the incidence of PDNV within 8 h post-sedation. Secondary outcomes included PDNV frequency and severity at 8-24, 0-24, and 24-48 h and side effects of medications. The incidence of PDNV within 8 h post-sedation was 37.66% (29/77). The PS group showed a significantly lower PDNV rate of 2.56% within 8 h, compared to the P group (35.71%, P < .001), S group (19.64%, P < .001), and control group (38.39%, P < .001), respectively. The S group (19.64%) also had a lower rate than the P group (35.71%, P = .007) and the control group (38.39%, P = .002). Subgroup analysis suggested a potential differential effect of palonosetron in reducing vomiting among male patients undergoing gastrointestinal procedures. The combination therapy was also associated with fewer cases of mild or no nausea and vomiting. In summary, the incidence of PDNV following sedation with nalbuphine and etomidate was notably high. The combination of scopolamine and palonosetron was more effective in preventing PDNV, with implications for improved post-sedation care.
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Affiliation(s)
- Jianghuai Lin
- Department of Anesthesiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China
| | - Zhiming Cai
- Department of Anesthesiology and Perioperative Medicine, 900 Hospital of the Joint Logistic Support Force, Fuzhou, Fujian, China
| | - Yingzi Lin
- Department of Anesthesiology, Sanming First Hospital, Sanming, Fujian, China
| | - Huanghui Wu
- Translational Research Institute of Brain and Brain-Like Intelligence, Shanghai Key Laboratory of Anesthesiology and Brain Functional Modulation, Department of Anesthesiology and Perioperative Medicine, Shanghai Fourth People's Hospital, School of Medicine, Tongji University, Shanghai, China
| | - Yu Gu
- Department of Anesthesiology, Zigong Fourth People's Hospital, Zigong, Sichuan, China
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Saeed A, Elewidi M, Nawlo A, Elzahaby A, Khaled A, Othman A, Abuelazm M, Abdelazeem B. Efficacy and safety of ciprofol versus propofol for induction of general anaesthesia or sedation: A systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth 2024; 68:776-794. [PMID: 39386394 PMCID: PMC11460804 DOI: 10.4103/ija.ija_104_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/30/2024] [Revised: 06/28/2024] [Accepted: 07/07/2024] [Indexed: 10/12/2024] Open
Abstract
Background and Aims Propofol has been used in medical practice as an anaesthetic drug for producing and sustaining general anaesthesia due to its advantages. However, it also has drawbacks, including injection-related discomfort. Recently, ciprofol has emerged as a promising anaesthetic drug that may overcome many drawbacks associated with propofol. In this systematic review and meta-analysis, we assess the efficacy and safety of ciprofol compared to propofol in different anaesthesia procedures. Methods The study protocol was registered in the International Prospective Register of Systematic Reviews (ID: CRD42023458170). Central, PubMed, EMBASE, Scopus and WOS were searched for English literature until 26 February 2024. Meta-analysis was performed using RevMan. The risk of bias was assessed using the RoB 2.0 tool. Results were reported as risk ratios (RRs), mean differences (MDs) and 95% confidence intervals (CIs). Results Nineteen randomised controlled trials were included in our analysis, with 2841 participants. There was no difference between ciprofol and propofol in the success rate of endoscopy (RR: 1.01, 95% CI: 0.99, 1.02; P = 0.44), while ciprofol showed a significant increase in the success rate of general anaesthesia/sedation (RR: 1.01, 95% CI: 1.00, 1.02; P = 0.04). Ciprofol showed significantly lower pain on injection (RR: 0.14, 95% CI: 0.09, 0.22; P < 0.001), lower adverse events (RR: 0.80, 95% CI: 0.69, 0.92; P = 0.002) and higher patient satisfaction (standardised mean difference (SMD): 0.36, 95% CI: 0.24, 0.48; P < 0.001). Conclusion Ciprofol exhibited a comparable efficacy to propofol in inducing general anaesthesia and sedation with fewer adverse events, less pain on injection and higher patient satisfaction. These collective findings may suggest that ciprofol can be used as an alternative drug to ensure effective general anaesthesia/sedation induction in the future.
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Affiliation(s)
- Abdallah Saeed
- Faculty of Medicine, Tanta University, Tanta, Gharbia, Egypt
| | - Mariam Elewidi
- Faculty of Medicine, Tanta University, Tanta, Gharbia, Egypt
| | - Ahmad Nawlo
- Department of Infectious Diseases, Brigham and Women’s Hospital, Harvard Medical School, Boston, West Virginia, USA
| | - Amr Elzahaby
- Faculty of Medicine, Tanta University, Tanta, Gharbia, Egypt
| | - Asmaa Khaled
- Faculty of Medicine, Tanta University, Tanta, Gharbia, Egypt
| | - Abdalla Othman
- Faculty of Medicine, Tanta University, Tanta, Gharbia, Egypt
| | | | - Basel Abdelazeem
- Department of Cardiology, West Virginia University, Morgantown, West Virginia, USA
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Zhao Z, Jin X, Li Y, Wang X, Cui Y, Zhang B, Kang Y, Zhang G, Chu Q, Zhang J. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients: protocol for a prospective, single-center, randomized, double-blind, non-inferiority trial. Front Pharmacol 2024; 15:1378081. [PMID: 39175547 PMCID: PMC11338772 DOI: 10.3389/fphar.2024.1378081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2024] [Accepted: 07/26/2024] [Indexed: 08/24/2024] Open
Abstract
Introduction Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties when compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients. Methods and analysis This is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 patients aged 65 years or older, who are scheduled for same-day bidirectional endoscopy under sedation, will be randomly allocated, in a 1:1 ratio, to either fospropofol group or propofol group (n = 128 in each group). All patients will receive analgesic pre-treatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to achieve target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events concerning cough reflex, gag reflexes, body movement, muscular tremor, and pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), and bradycardia, will also be recorded. Data will be analyzed on an intention-to-treat basis. Discussion We hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. Our findings will potentially provide a new sedation regimen for same-visit bidirectional endoscopy in elderly patients. Clinical Trial Registration clinicaltrials.gov, identifier NCT02875639.
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Affiliation(s)
- Zhe Zhao
- Department of Geriatrics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Xiaogao Jin
- Department of Anesthesiology, The Second Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, China
| | - Yong Li
- Department of Anesthesiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Xiaofeng Wang
- Department of Anesthesiology, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Yongchen Cui
- Department of Anesthesiology, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
| | - Bing Zhang
- Department of Anesthesiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Yu Kang
- Department of Anesthesiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Guangming Zhang
- Department of Anesthesiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
| | - Qinjun Chu
- Department of Anesthesiology and Perioperative Medicine, Zhengzhou Central Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
| | - Junfeng Zhang
- Department of Anesthesiology, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China
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Ba K, Ni D, Du R, Wei X. Advantages of remimazolam for sedation in impacted tooth extraction. HUA XI KOU QIANG YI XUE ZA ZHI = HUAXI KOUQIANG YIXUE ZAZHI = WEST CHINA JOURNAL OF STOMATOLOGY 2024; 42:476-480. [PMID: 39049635 PMCID: PMC11338492 DOI: 10.7518/hxkq.2024.2023450] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 12/25/2023] [Revised: 04/28/2024] [Indexed: 07/27/2024]
Abstract
OBJECTIVES This study aims to compare the sedative effects of remimazolam and midazolam during impacted tooth extraction to provide a comfortable sedation treatment for patients with dental anxiety. METHODS A prospective randomized controlled trial was conducted, in which 60 patients undergoing intravenous sedation for mandibular impacted third molar extraction were evenly divided into either the remimazolam or midazolam group. Prior to receiving a nerve blocker, the patients were sedated with remimazolam or midazolam. Various parameters were recorded and analyzed, including onset time, awakening time, recovery time, modified dental anxiety scale (MDAS) scores before and after surgery, patient-doctor satisfaction levels, postoperative side effects within 24 hours, heart rate (HR), and mean arterial pressure (MAP) at different time points. RESULTS Compared with the midazolam group, patients in the remimazolam group demonstrated significantly shorter onset, awakening, and recovery times as well as lower postoperative MDAS scores and higher levels of patient-doctor satisfaction. Fewer postoperative side effects were reported in the remimazolam group, although the differences were not statistically significant. CONCLUSIONS The use of remimazolam demonstrates faster onset and recovery, superior efficacy in reducing dental anxiety, and enhanced satisfaction among patients and doctors, thereby presenting distinct advantages for sedation treatment for patients with dental anxiety.
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Affiliation(s)
- Kai Ba
- Dept. of Stomatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Duan Ni
- Dept. of Anesthesiology, Armed Police Corps Hospital of Henan, Zhengzhou 450000, China
| | - Ruobing Du
- Dept. of Stomatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
| | - Xueqin Wei
- Dept. of Stomatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China
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Sun Q, Cheng J, Lei W, Lu X, Huang Y, Sun J. The effects of remimazolam combined with sufentanil on respiration, circulation and sedation level in patients undergoing colonoscopy. BMC Anesthesiol 2024; 24:252. [PMID: 39054423 PMCID: PMC11271046 DOI: 10.1186/s12871-024-02644-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2023] [Accepted: 07/17/2024] [Indexed: 07/27/2024] Open
Abstract
BACKGROUND The main sedative which is propofol in painless gastroenteroscopy, has a high risk of reducing blood pressure and respiratory depression. Remimazolam (a short-acting benzodiazepine) is expected to be widely used in painless gastroenteroscopy due to its rapid onset, rapid metabolism and light respiratory and circulation inhibition. METHODS A randomized, single-blind, parallel, controlled study, 123 outpatients who were undergoing painless colonoscopy and ramdomly divided into group A, B and C, in Hangzhou First People's Hospital, July-December 2021. All patients were intravenously injected with 5 µg sufentanil for analgesic preconditioning. The group A was induced by 0.2 mg/kg remimazolam besylate. The group B was induced by 0.25 mg/kg remimazolam besylate. And the group C was inducted by 2.0 mg /kg propofol. If the patients had limb movement or MOAA/S score > 3 and so on, remimazolam besylate was added at 2.5 mg/ time in group A and B, and propofol emulsion injection was added at 0.5 mg/kg/ time in group C. During the operation, according to the actual situation, remimazolam was per added 2.5 mg in the experimental group, and propofol was 0.5 mg/kg in the control group. Heart rate (HR), non-invasive blood pressure (BP), respiratory rate (RR), pulse oxygen saturation (SpO2), and improved vigilance/sedation score (MOAA/S) of patients was recorded from entering endoscopy room to get out of the anesthesia recovery room, also including perioperative adverse events, other medications or treatments, the time of patients waking up and leaving the hospital. RESULTS The successful rate of induction in three groups was 100%. There was no significant difference in the sedation completion rate among the three groups (Group A:90.2%, Group B: 92.7%, Group C: 92.7%, P = 1.000). The rate of adverse events after administration: group A(27.0%) and B(36.8%) both lower than group C(71.0%),P < 0.001;There was no significant difference between group A and group B, P > 0.744;The average time from the last drug administration to meet the discharge criteria of the subjects in three groups was as follows: The average time of group A(16.2 min) and Group B(16.5 min) both shorter than group C(19.6 min), P = 0.001; There was no significant difference between group A and group B, P = 0.742. CONCLUSIONS This study revealed that remimazolam is a safe and effective medication for colonoscopy sedation, the security of remimazolam is better than propofol, and the sedative effect with the initial dose of 0.25 mg/kg of remimazolam is optimal. TRIAL REGISTRATION China Clinical Trial Center with registration number: 2100052615,02/11/2021.
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Affiliation(s)
- Qirui Sun
- Department of Anesthesiology, Chengbei Branch of Hangzhou First People's Hospital (Hangzhou Geriatric Hospital), Hangzhou, 310000, China
- Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China
- School of Second Clinical Medical College, Wenzhou Medical University, Wenzhou, 310053, Zhejiang, China
| | - Jiating Cheng
- School of Second Clinical Medical College, Wenzhou Medical University, Wenzhou, 310053, Zhejiang, China
- Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, China
| | - Weiping Lei
- Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China
| | - Xinlei Lu
- Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China
| | - Yaqin Huang
- Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China
| | - Jianliang Sun
- Department of Anesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, 310000, China.
- School of Second Clinical Medical College, Wenzhou Medical University, Wenzhou, 310053, Zhejiang, China.
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Brohan M, Brohan J, Goudra B. Remimazolam and Its Place in the Current Landscape of Procedural Sedation and General Anesthesia. J Clin Med 2024; 13:4362. [PMID: 39124629 PMCID: PMC11312559 DOI: 10.3390/jcm13154362] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/28/2024] [Revised: 07/19/2024] [Accepted: 07/24/2024] [Indexed: 08/12/2024] Open
Abstract
Remimazolam was derived from its parent compound by adding an ester linkage into its structure so that the drug becomes a substrate for ester metabolism. As a result, it undergoes organ-independent ester hydrolysis, although the clinical benefits in terms of shorter recovery are not uniformly observed in clinical practice. Remimazolam is mainly tested in procedural sedation. In comparison to propofol, the current gold standard for procedural sedation, its proposed attractiveness is shorter wake-up times and a clear-headed recovery. Its clear advantages over propofol are better hemodynamic stability, lack of pain on injection and availability of a reversal agent in the form of flumazenil. Data on patient and proceduralist satisfaction are lacking. Remimazolam is also used for induction and maintenance of general anesthesia in Japan (where it is approved for this purpose). In this scenario, it is not clear if it can achieve the same degree of lack of recall as propofol. The use of remimazolam in obstetrics, pediatrics and high-risk populations is an emerging area.
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Affiliation(s)
- Matthew Brohan
- Resident in Anesthesiology, School of Medicine, University College Cork, T12 K8AF Cork, Ireland;
| | | | - Basavana Goudra
- Honickman Center, Department of Anesthesiology, Sidney Kimmel Medical College, Jefferson Health, Philadelphia, PA 19107, USA
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Ho CH, Chang CY, Lu CW. A Comparison of Hypotension, Bradycardia, and Hypoxia Incidence between the Use of Remimazolam and Other Sedative Agents during Colonoscopy Procedures: A Systematic Review and Meta-Analysis. J Clin Med 2024; 13:4352. [PMID: 39124618 PMCID: PMC11313025 DOI: 10.3390/jcm13154352] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Revised: 07/19/2024] [Accepted: 07/20/2024] [Indexed: 08/12/2024] Open
Abstract
(1) Background: Remimazolam is a newly developed sedative agent. The results of previous meta-analyses highlight the strengths of remimazolam for use during colonoscopy procedures. The primary aim of the present study was to investigate whether, in patients undergoing colonoscopy procedures (P), the use of remimazolam (I) compared with other sedative agents (C) could lead to a greater incidence of hypotension, bradycardia, and hypoxia (O). (2) Methods: In the following study, we conducted an extensive literature search using two electronic databases. We included all randomized control trials, which involved a comparison of the hemodynamic changes in remimazolam versus a placebo and other sedative agents during colonoscopy procedures. Data extraction, data synthesis, and the assessment of risk of bias were performed by the authors. (3) Results: A total of seven articles met our inclusion criteria. The combined analysis of the selected studies revealed no statistically significant difference in hypotension, bradycardia, or hypoxia incidence when comparing remimazolam and the control group. However, in comparison with the group administered propofol, the pooled data of the selected studies revealed statistically significant differences in the incidence of both hypotension and bradycardia but not hypoxia. (4) Conclusions: Our findings indicate that there is no significant difference in hypotension, bradycardia, and hypoxia incidence when comparing remimazolam and other agents. Nevertheless, when comparing the remimazolam and propofol groups, the results demonstrated statistically significant differences in the incidence of both hypotension and bradycardia but not hypoxia.
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Affiliation(s)
- Chia-Hao Ho
- Department of Anesthesiology, Far Eastern Memorial Hospital, New Taipei City 22060, Taiwan; (C.-H.H.); (C.-Y.C.)
| | - Cheng-Ying Chang
- Department of Anesthesiology, Far Eastern Memorial Hospital, New Taipei City 22060, Taiwan; (C.-H.H.); (C.-Y.C.)
| | - Cheng-Wei Lu
- Department of Anesthesiology, Far Eastern Memorial Hospital, New Taipei City 22060, Taiwan; (C.-H.H.); (C.-Y.C.)
- Department of Mechanical Engineering, Yuan Ze University, Taoyuan 32003, Taiwan
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Wang Z, Ma J, Liu X, Gao J. Development and validation of a predictive model for PACU hypotension in elderly patients undergoing sedated gastrointestinal endoscopy. Aging Clin Exp Res 2024; 36:149. [PMID: 39023685 PMCID: PMC11258065 DOI: 10.1007/s40520-024-02807-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2024] [Accepted: 07/05/2024] [Indexed: 07/20/2024]
Abstract
BACKGROUND Hypotension, characterized by abnormally low blood pressure, is a frequently observed adverse event in sedated gastrointestinal endoscopy procedures. Although the examination time is typically short, hypotension during and after gastroscopy procedures is frequently overlooked or remains undetected. This study aimed to construct a risk nomogram for post-anesthesia care unit (PACU) hypotension in elderly patients undergoing sedated gastrointestinal endoscopy. METHODS This study involved 2919 elderly patients who underwent sedated gastrointestinal endoscopy. A preoperative questionnaire was used to collect data on patient characteristics; intraoperative medication use and adverse events were also recorded. The primary objective of the study was to evaluate the risk of PACU hypotension in these patients. To achieve this, the least absolute shrinkage and selection operator (LASSO) regression analysis method was used to optimize variable selection, involving cyclic coordinate descent with tenfold cross-validation. Subsequently, multivariable logistic regression analysis was applied to build a predictive model using the selected predictors from the LASSO regression. A nomogram was visually developed based on these variables. To validate the model, a calibration plot, receiver operating characteristic (ROC) curve, and decision curve analysis (DCA) were used. Additionally, external validation was conducted to further assess the model's performance. RESULTS The LASSO regression analysis identified predictors associated with an increased risk of adverse events during surgery: age, duration of preoperative water abstinence, intraoperative mean arterial pressure (MAP) <65 mmHg, decreased systolic blood pressure (SBP), and use of norepinephrine (NE). The constructed model based on these predictors demonstrated moderate predictive ability, with an area under the ROC curve of 0.710 in the training set and 0.778 in the validation set. The DCA indicated that the nomogram had clinical applicability when the risk threshold ranged between 20 and 82%, which was subsequently confirmed in the external validation with a range of 18-92%. CONCLUSION Incorporating factors such as age, duration of preoperative water abstinence, intraoperative MAP <65 mmHg, decreased SBP, and use of NE in the risk nomogram increased its usefulness for predicting PACU hypotension risk in elderly patient undergoing sedated gastrointestinal endoscopy.
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Affiliation(s)
- Zi Wang
- Department of Anesthesiology, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Jiangsu, Yangzhou, 225001, China
- Yangzhou University, Jiangsu, Yangzhou, 225001, China
| | - Juan Ma
- Department of Anesthesiology, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Jiangsu, Yangzhou, 225001, China
- Yangzhou University, Jiangsu, Yangzhou, 225001, China
| | - Xin Liu
- Department of Anesthesiology, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Jiangsu, Yangzhou, 225001, China
| | - Ju Gao
- Department of Anesthesiology, Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Jiangsu, Yangzhou, 225001, China.
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Dahiya DS, Kumar G, Parsa S, Gangwani MK, Ali H, Sohail AH, Alsakarneh S, Hayat U, Malik S, Shah YR, Pinnam BSM, Singh S, Mohamed I, Rao A, Chandan S, Al-Haddad M. Remimazolam for sedation in gastrointestinal endoscopy: A comprehensive review. World J Gastrointest Endosc 2024; 16:385-395. [PMID: 39072252 PMCID: PMC11271717 DOI: 10.4253/wjge.v16.i7.385] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2024] [Revised: 05/05/2024] [Accepted: 06/04/2024] [Indexed: 07/08/2024] Open
Abstract
Worldwide, a majority of routine endoscopic procedures are performed under some form of sedation to maximize patient comfort. Propofol, benzodiazepines and opioids continue to be widely used. However, in recent years, Remimazolam is gaining immense popularity for procedural sedation in gastrointestinal (GI) endoscopy. It is an ultra-short-acting benzodiazepine sedative which was approved by the Food and Drug Administration in July 2020 for use in procedural sedation. Remimazolam has shown a favorable pharmacokinetic and pharmacodynamic profile in terms of its non-specific metabolism by tissue esterase, volume of distribution, total body clearance, and negligible drug-drug interactions. It also has satisfactory efficacy and has achieved high rates of successful sedation in GI endoscopy. Furthermore, studies have demonstrated that the efficacy of Remimazolam is non-inferior to Propofol, which is currently a gold standard for procedural sedation in most parts of the world. However, the use of Propofol is associated with hemodynamic instability and respiratory depression. In contrast, Remimazolam has lower incidence of these adverse effects intra-procedurally and hence, may provide a safer alternative to Propofol in procedural sedation. In this comprehensive narrative review, highlight the pharmacologic characteristics, efficacy, and safety of Remimazolam for procedural sedation. We also discuss the potential of Remimazolam as a suitable alternative and how it can shape the future of procedural sedation in gastroenterology.
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Affiliation(s)
- Dushyant Singh Dahiya
- Division of Gastroenterology, Hepatology & Motility, The University of Kansas School of Medicine, Kansas City, MO 66160, United States
| | - Ganesh Kumar
- Department of Internal Medicine, Chandka Medical College, Sindh 77280, Pakistan
| | - Syeda Parsa
- Department of Internal Medicine, Chandka Medical College, Sindh 77280, Pakistan
| | - Manesh Kumar Gangwani
- Department of Gastroenterology and Hepatology, University of Arkansas For Medical Sciences, Little Rock, AR 72205, United States
| | - Hassam Ali
- Division of Gastroenterology, Hepatology and Nutrition, East Carolina University/Brody School of Medicine, Greenville, NC 27858, United States
| | - Amir Humza Sohail
- Department of Surgery, University of New Mexico School of Medicine, Albuquerque, NM 87106, United States
| | - Saqr Alsakarneh
- Department of Internal Medicine, University of Missouri-Kansas City, Kansas City, MO 64108, United States
| | - Umar Hayat
- Department of Internal Medicine, Geisinger Wyoming Valley Medical Center, Wilkes Barre, PA 18711, United States
| | - Sheza Malik
- Department of Internal Medicine, Rochester General Hospital, Rochester, NY 14621, United States
| | - Yash R Shah
- Department of Internal Medicine, Trinity Health Oakland/Wayne State University, Pontiac, MI 48341, United States
| | - Bhanu Siva Mohan Pinnam
- Department of Internal Medicine, John H. Stroger Hospital of Cook County, Chicago, IL 60612, United States
| | - Sahib Singh
- Department of Internal Medicine, Sinai hospital, Baltimore, MD 21215, United States
| | - Islam Mohamed
- Department of Hepatology, University of Missouri, Columbia, MO 65211, United States
| | - Adishwar Rao
- Department of Internal Medicine, Guthrie Robert Packer Hospital, Sayre, PA 18840, United States
| | - Saurabh Chandan
- Division of Gastroenterology and Hepatology, Creighton University School of Medicine, Omaha, NE 68131, United States
| | - Mohammad Al-Haddad
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN 46202, United States
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Zhang Q, Zhao R, Wu Y, Zhang L, Feng Y. Etomidate Combined with Propofol versus Remimazolam for Sedation in Elderly Patients During Gastrointestinal Endoscopy: A Randomized Prospective Clinical Trial. Drug Des Devel Ther 2024; 18:2681-2692. [PMID: 38974124 PMCID: PMC11227308 DOI: 10.2147/dddt.s454314] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2023] [Accepted: 06/25/2024] [Indexed: 07/09/2024] Open
Abstract
Purpose Remimazolam is a novel short-acting benzodiazepine used for sedation and general anesthesia. This study aimed to evaluate the efficacy and safety of remimazolam besylate in elderly patients who underwent diagnostic gastrointestinal endoscopy. Patients and Methods A total of 120 patients aged 60-75 years were randomly allocated to one of two groups. Remifentanil 0.3μg/kg was used for analgesia. Patients were administered remimazolam besylate 7 mg (R group) or etomidate 0.1 mg/kg combined with 1% propofol 0.5 mg/kg (EP group) for induction, supplemental repeated doses were given as needed. Some time metrics, vital signs, adverse events were evaluated. Patients' Mini-cog score and recovery questionnaires were compared. Results Compared to the EP group, the induction time was slightly longer in the R group (1.50 VS 1.15 minutes) (P<0.05), the time spent in the post-anesthesia care unit (PACU) was shorter (15.17 VS 17.40 minutes) (P<0.05). Compare with EP group, SBP was lower in R group at T15 and T25 time point, but heart rate was higher in T2, T3, T5 (P< 0.05). The Mini-Cog score was higher after the procedure (2.83 VS 2.58) (P<0.05). The incidence of respiratory adverse events was higher in the EP group than R group (18.3% VS 5.0%, P < 0.05). The most common adverse event in R group was hiccups. The sedation satisfaction rate and degree of amnesia were higher in the R group (66.7% VS 11.7%) (P < 0.05), and the effect on patient's life within 24 hours was lower (12.0% VS 30.5%) (P < 0.05). Conclusion The safety and efficacy of remimazolam besylate are not inferior to those of etomidate combined with propofol, rendering it a safe option for sedation during gastrointestinal endoscopy in ASA I-II elderly patients, but care should be taken to monitor the occurrence of hiccups.
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Affiliation(s)
- Qin Zhang
- Endoscopy Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Rui Zhao
- Endoscopy Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Yaqing Wu
- Department of Anesthesiology, Peking University People's Hospital, Beijing, People's Republic of China
| | - Liming Zhang
- Endoscopy Center, Peking University People's Hospital, Beijing, People's Republic of China
| | - Yi Feng
- Department of Anesthesiology, Peking University People's Hospital, Beijing, People's Republic of China
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Zhao S, Hamo A, Ottenhof N, Korstanje JWH, Dauwels J. Prediction of Postinduction Hypotension by Machine Learning. ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. ANNUAL INTERNATIONAL CONFERENCE 2024; 2024:1-4. [PMID: 40039111 DOI: 10.1109/embc53108.2024.10782974] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 03/06/2025]
Abstract
Post-induction hypotension (PIH) occurs shortly after anesthesia induction and is related to several post-operative complications. Medications delivered during induction and maintenance of anesthesia are significantly related to PIH occurrence, which remains common due to the intricate nature of clinical factors. To enhance decision-making on anesthestic dosing, machine learning (ML) is proposed to predict the risk of PIH associated with specific anesthetic dosages. This study focuses on the development of a prediction model for PIH to support anesthesia decision-making. Trained on 320 cases from the VitalDB database, the model incorporates demographic data, vital signs, and medication dosing information. By including the dosage of propofol administered during the induction period as an input variable, the algorithm predicts PIH risk before induction, providing valuable insights into the safety of propofol dosage plans. The results were validated using nested cross-validation, achieving high performance (precision of 0.83 and recall of 0.84). Moreover, an advisory model demonstrates the potential for personalizing a safe propofol anesthetics range for an individual patient.
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