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Huang PY, Ke HH, Cheng HW, Hsu PK, Chang WK, Ting CK. Effect of remimazolam in non-intubated video-assisted thoracic surgery: a retrospective cohort study. BMC Anesthesiol 2025; 25:263. [PMID: 40413418 DOI: 10.1186/s12871-025-03131-w] [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: 12/11/2024] [Accepted: 05/09/2025] [Indexed: 05/27/2025] Open
Abstract
BACKGROUND Single-incision video-assisted thoracoscopic surgery (VATS) is safer, more efficient, and less invasive, with fewer complications and shorter hospital stays. When combined with non-intubated spontaneous breathing, it enhances recovery by reducing complications, operating time, and anesthesia duration. Remimazolam, an ultrashort-acting benzodiazepine, provides rapid onset and offset with minimal respiratory depression, making it promising for non-intubated VATS (NIVATS). METHODS This retrospective study was conducted at Taipei Veterans General Hospital, Taiwan, and included 62 patients who underwent single-port NIVATS. Of these, 41 patients received propofol with dexmedetomidine (August 2019-December 2021), and 21 patients received remimazolam with dexmedetomidine (January 2023-December 2023). The primary outcome was the change in arterial carbon dioxide pressure (ΔPaCO2), while secondary outcomes included anesthesia duration, surgery duration, and postoperative hospital stay. Propensity score matching controlled for confounders, and subgroup analyses compared thoracic epidural anesthesia (TEA) with paravertebral block (PVB). RESULTS The patients in the remimazolam group showed a smaller PaCO2 increase (6.84 ± 6.01 mmHg vs. 14.42 ± 11.55 mmHg; p = 0.0113), shorter surgery duration (50.19 ± 26.12 min vs. 83.54 ± 24.86 min; p < 0.0001), and shorter postoperative hospital stay compared with those in the propofol group. No significant between-group differences were found with regard to anesthesia duration. Subgroup analysis showed consistent outcomes between TEA and PVB groups, supporting the flexibility of remimazolam-based sedation. None of the patients required flumazenil reversal. CONCLUSIONS This study demonstrated effective sedation and superior respiratory stability with the use of remimazolam-dexmedetomidine combination in NIVATS, suggesting it to be a viable alternative. Further studies are needed to confirm these findings in diverse surgical settings.
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Affiliation(s)
- Po-Yu Huang
- Department of Anesthesiology, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City, 11217, Taiwan, R.O.C
| | - Hui-Hsuan Ke
- Department of Anesthesiology, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City, 11217, Taiwan, R.O.C
| | - Hung-Wei Cheng
- Department of Anesthesiology, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City, 11217, Taiwan, R.O.C
| | - Po-Kuei Hsu
- Department of Surgery, Division of Thoracic Surgery, Taipei Veterans General Hospital, Taipei, Taiwan
| | - Wen-Kuei Chang
- Department of Anesthesiology, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City, 11217, Taiwan, R.O.C
| | - Chien-Kun Ting
- Department of Anesthesiology, Taipei Veterans General Hospital, No. 201, Sec. 2, Shipai Rd., Beitou District, Taipei City, 11217, Taiwan, R.O.C..
- Institute of Emergency and Critical Care Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
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Andreassen S, Nielsen VML, Krarup AL, Kamp A, Andersen DM, Krogh-Larsen S, Melgaard D. Remimazolam for procedural sedation in the emergency department: a prospective study of effectiveness and patient satisfaction. Scand J Trauma Resusc Emerg Med 2025; 33:93. [PMID: 40394649 DOI: 10.1186/s13049-025-01402-6] [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: 01/09/2025] [Accepted: 04/28/2025] [Indexed: 05/22/2025] Open
Abstract
BACKGROUND Remimazolam (RM) is a novel ultra-short acting benzodiazepine. This study evaluates the safety of using RM for procedural sedation in the emergency department (ED) comparing its administration by registered nurse anaesthetists versus house officers in 1st year residency in emergency medicine and emergency medicine physicians without previous anaesthesiologic specialisation. Secondary aims were patient satisfaction and proportion of successful procedures. METHODS This prospective study was performed at the ED at Aalborg University Hospital from 10 May through 20 August 2024. Five emergency medicine physicians (group 1) started administering RM to patients after completion of training and direct supervision. Results were compared to patients sedated by two registered nurse anaesthetists (group 2) who had been administering RM more than 50 times before study start. Time was recorded during sedation and a questionnaire filled out immediately after the patient had awakened. T-tests or Mann-Whitney U tests were used to compare groups. Proportions were calculated with chi-square (χ2) tests of proportion. RESULTS In group 1, 53 patients were sedated by emergency medicine physicians, and in group 2, 50 patients were sedated by registered nurse anaesthetists. No or mild respiratory adverse effects were observed in 97% of patients in group 1 versus 100% in group 2. Procedural amnesia was 93% in group 1 versus 90% in group 2. Patients were safe to be left unsupervised after a median of 15 min in both groups. Procedural success was 92% in group 1 versus 100% in group 2. CONCLUSIONS Severe respiratory adverse effects after sedation were rare in both groups. Most patients had amnesia and adequate pain relief for the procedure. The use of RM by physicians without anaesthesiologic specialisation is considered a safe and effective alternative for procedural sedation in the ED. TRIAL REGISTRATION The study was registered and approved as a quality study (ID 2017-011259) by the hospital administration.
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Affiliation(s)
- Sofus Andreassen
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
| | - Vibe Maria Laden Nielsen
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
| | - Anne Lund Krarup
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
| | - Annika Kamp
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
| | - Dennis Møller Andersen
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
| | - Steven Krogh-Larsen
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark
| | - Dorte Melgaard
- Department of Emergency Medicine and Trauma Centre, Aalborg University Hospital, Hobrovej 18-22, EMRUn, Aalborg, 9000, Denmark.
- Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
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Chai B, Guo J, Xu Z, Chen T, Wang H, Zhu Z, Zhong J, Chen K, Du J, Kang X. Comparison of the efficacy and safety of remimazolam and propofol for fiberoptic bronchoscopy in older patients: a prospective, randomized controlled study. BMC Geriatr 2025; 25:337. [PMID: 40369438 PMCID: PMC12076816 DOI: 10.1186/s12877-025-05984-9] [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: 05/21/2024] [Accepted: 04/24/2025] [Indexed: 05/16/2025] Open
Abstract
OBJECTIVE The aim of this study was to compare the efficacy and safety of remimazolam with those of propofol in older patients undergoing fiberoptic bronchoscopy with preserved spontaneous breathing. METHODS Sixty older patients were randomly and equally divided into a remimazolam group (group R) and a propofol group (group P). Both groups received 0.15 µg/kg of sufentanil for analgesia. Group R received an initial dose of 0.2 mg/kg remimazolam and was injected with a maintenance dose of 1 mg/kg/h. Group P received an initial dose of 2 mg/kg propofol and was injected with a maintenance dose of 4 mg/kg/h. The primary evaluation indicators were the success rate of sedation and the incidence of hypotension. The secondary evaluation indicators were respiratory depression, hypertension, tachycardia, bradycardia, awakening time, quality of recovery-15 (QOR-15) score, patient satisfaction, physician satisfaction, and adverse events. RESULTS Success rates of sedation were similar between group R (96.7%) and group P (100%). The incidence of hypotension in group R was lower than that in group P (2/30 vs. 10/30, p = 0.01). Respiratory depression was lower in group R than in group P (3/30 vs. 10/30, p = 0.03). Fewer patients reported injection pain in group R (0/30 vs. 7/30, p = 0.01). There were no significant differences in hypertension, tachycardia, bradycardia, awakening time, QoR-15 score, patient satisfaction, physician satisfaction, or adverse events between the two groups. CONCLUSIONS Remimazolam has a high sedation success rate for painless fiberoptic bronchoscopy in older patients, and the incidence of hypotension and respiratory depression is lower than that of propofol. Remimazolam may be a better choice for sedation during painless fiberoptic bronchoscopy in older patients with preserved spontaneous breathing. TRIAL REGISTRATION ChiCTR2300069041; 6/3/2023.
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Affiliation(s)
- Binggao Chai
- Department of Anesthesiology, Tongxiang First People's Hospital, Tongxiang, China
| | - Jiaxi Guo
- Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
| | - Zhiwei Xu
- Department of Breast Surgery, Tongxiang First People's Hospital, Tongxiang, China
| | - Tao Chen
- Department of Anesthesiology, Tongxiang First People's Hospital, Tongxiang, China
| | - Hongquan Wang
- Department of Respiratory Medicine, Tongxiang First People's Hospital, Tongxiang, China
| | - Zhenqiang Zhu
- Department of Anesthesiology, Tongxiang First People's Hospital, Tongxiang, China
| | - Jian Zhong
- Department of Anesthesiology, Tongxiang First People's Hospital, Tongxiang, China
| | - Kanzheng Chen
- Department of Respiratory Medicine, Tongxiang First People's Hospital, Tongxiang, China
| | - Jianlong Du
- Department of Anesthesiology, Tongxiang First People's Hospital, Tongxiang, China.
| | - Xianhui Kang
- Department of Anesthesiology, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
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Webb CF, Evers J, Kane C, Minton LA, York NL, Owens HL. Caring for the Patient During Bedside Bronchoscopy in the Critical Care Setting. Dimens Crit Care Nurs 2025; 44:114-120. [PMID: 40163333 DOI: 10.1097/dcc.0000000000000695] [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: 04/02/2025] Open
Abstract
BACKGROUND Bedside bronchoscopy is a pivotal diagnostic and therapeutic tool often used with critically ill patients in the critical care setting. Bronchoscopy allows for direct visualization of the airways and lung parenchyma and can be useful in evaluating different bronchopulmonary diseases including foreign bodies, tumors, infectious and inflammatory conditions, airway stenosis, and bronchopulmonary hemorrhage. OBJECTIVE This article explores bedside bronchoscopy in critically ill patients. Covering key areas from preprocedure preparation care, it emphasizes the nurse's role, procedural techniques, and adaptations. The focus extends to nurses' roles with emerging bedside bronchoscopy technologies and provides insight on implications for clinical practice. CONCLUSION Bedside bronchoscopy serves as a vital tool in critical care, enabling both diagnosis and treatment of various pulmonary conditions. Nurses play a pivotal role in ensuring procedural success and patient safety, from preprocedure preparation to postprocedure monitoring. As technology evolves, nurses must adapt, embracing opportunities for ongoing learning and interdisciplinary collaboration, while also advocating for patient-centered care and ethical considerations in the integration of advanced technologies.
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Eleveld DJ, Colin PJ, Van den Berg JP, Koomen JV, Stoehr T, Struys MMRF. Development and analysis of a remimazolam pharmacokinetics and pharmacodynamics model with proposed dosing and concentrations for anaesthesia and sedation. Br J Anaesth 2025:S0007-0912(25)00192-8. [PMID: 40312166 DOI: 10.1016/j.bja.2025.02.038] [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: 08/11/2024] [Revised: 01/31/2025] [Accepted: 02/20/2025] [Indexed: 05/03/2025] Open
Abstract
BACKGROUND Pharmacokinetic-pharmacodynamic (PK-PD) models of remimazolam and their covariate relationships are useful for understanding drug disposition and predicting drug effects. Although clinical studies have shown that remimazolam induction doses decline with advancing age, this property is not reflected in existing models. The purpose of this investigation was to develop a PK-PD model for remimazolam and perform covariate analysis to maximise its utility across broad, diverse populations and to evaluate its consistency with clinical observations of drug dosing. METHODS Arterial and venous concentrations of remimazolam and its metabolite, Modified Observer's Assessment of Alertness and Sedation score and bispectral index were determined in 20 studies. Final population models were developed with covariate analysis. Simulations of drug administration for sedation and anaesthesia for this and previously published models were compared with the results of clinical studies. RESULTS Model development proceeded from 933 individuals aged 6-93 yr and weight 21-171 kg. PK data from studies with extracorporeal membrane oxygenation and treatment in ICU were considered in a post hoc analysis. Simulations of target-controlled infusion with the final model targeting sedation (Modified Observer's Assessment of Alertness and Sedation score 2 or 3) or anaesthesia (bispectral index 50) showed drug administration declining with age consistent with clinical observations. CONCLUSIONS A PK-PD model for remimazolam was developed for a broad, diverse population. Dosing and target concentrations are proposed that are clinically useful for anaesthesia and sedation, especially for target-controlled infusion administration.
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Affiliation(s)
- Douglas J Eleveld
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
| | - Pieter J Colin
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
| | - Johannes P Van den Berg
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
| | - Jeroen V Koomen
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
| | | | - Michel M R F Struys
- Department of Anesthesiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Department of Basic and Applied Medical Sciences, Ghent University, Ghent, Belgium
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Zhu K, Wu S, Hao X, Wang C. Successful sedation with remimazolam and alfentanil in a child susceptible to malignant hyperthermia: a case report. BMC Anesthesiol 2025; 25:207. [PMID: 40269725 PMCID: PMC12016150 DOI: 10.1186/s12871-025-03076-0] [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: 03/04/2025] [Accepted: 04/15/2025] [Indexed: 04/25/2025] Open
Abstract
BACKGROUND Malignant hyperthermia (MH) is a life-threatening autosomal-dominant disorder caused by mutations in the ryanodine receptor 1 (RYR1) gene, leading to calcium dysregulation in skeletal muscle. Patients with genetically confirmed MH susceptibility must strictly avoid volatile anesthetics and succinylcholine. Intravenous sedation presents a viable alternative, yet evidence supporting remimazolam use in pediatric MH patients remains scarce. CASE PRESENTATION We report the first case of a 1-year-old male patient with genetically confirmed MH susceptibility undergoing orchidopexy under remimazolam-alfentanil sedation combined with caudal block. The patient had no MH manifestations intraoperatively or postoperatively and recovered uneventfully. CONCLUSION This case demonstrates the feasibility of remimazolam-based sedation in genetically confirmed pediatric MH patients, supporting its safety profile in this population. Further multicenter studies are needed to establish standardized protocols.
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Affiliation(s)
- Kailai Zhu
- Department of Anesthesia, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Municipal Central Hospital, Lishui, 323000, Zhejiang Province, China
| | - Shuangwei Wu
- Department of Anesthesia, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Municipal Central Hospital, Lishui, 323000, Zhejiang Province, China
| | - Xianglin Hao
- Department of Anesthesia, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Municipal Central Hospital, Lishui, 323000, Zhejiang Province, China
| | - Chuanguang Wang
- Department of Anesthesia, The Fifth Affiliated Hospital of Wenzhou Medical University, Lishui Municipal Central Hospital, Lishui, 323000, Zhejiang Province, China.
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Zhang X, Li HX, Chen YR, Wang BN, Zheng H, Yan T. Safety and efficacy of remimazolam compared with propofol for general anesthesia during cold knife conization: a single-center, randomized controlled trial. BMC Anesthesiol 2025; 25:197. [PMID: 40269691 PMCID: PMC12016059 DOI: 10.1186/s12871-025-03066-2] [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: 12/29/2024] [Accepted: 04/10/2025] [Indexed: 04/25/2025] Open
Abstract
BACKGROUND Cold knife conization is usually performed under general anesthesia without intubation. This type of anesthesia is more critical in terms of the properties of the sedative drugs. Remimazolam is a novel ultrashort-acting benzodiazepine in which the lipid bond can be rapidly hydrolyzed by nonspecific lipases in the plasma. Therefore, remimazolam can be used for general anesthesia without intubation in patients undergoing short procedures. In this study, we compared the safety and efficacy of remimazolam with those of propofol for cold knife conization. METHODS This single-center, randomized controlled trial screened 104 patients, and 90 were randomly assigned to receive propofol (P, N = 45) or remimazolam (R, N = 45) during cold knife conization. All the patients received a 1 µg/kg fentanyl injection. The patients received 1.5 mg/kg propofol or 0.2 mg/kg remimazolam injection, followed by a rate of 4 ~ 12 mg/kg/h or 1.0 ~ 3.0 mg/kg/h continuous intravenous infusion, respectively, to keep the patient state index (PSi) between 35 and 50. The primary outcome was intraoperative hypoxemia. The secondary outcomes were hemodynamic parameters, respiratory parameters, and other adverse events. RESULTS The incidence of intraoperative hypoxemia in the R group was significantly lower than that in the P group (46.7% vs. 71.1%, p = 0.018). Compared with patients in the P group, patients in the R group had fewer changes in the respiratory rate, mean arterial pressure and heart rate at some time points during surgery. The incidences of hypotension (15.6% vs. 35.6%, p = 0.030) and injection pain (42.2% vs. 84.4%, p < 0.001) were lower in the R group than in the P group; however, patients in the R group required more time to awaken (7.9 ± 4.5 min vs. 4.3 ± 1.7 min, p < 0.001). CONCLUSION In conclusion, patients in the R group had a lower incidence of hypoxemia and fewer hemodynamic changes than did patients in the P group. Thus, remimazolam can be safely used for unintubated general anesthesia in patients undergoing cold knife conization. TRIAL REGISTRATION The trial registration number is ChiCTR2200065519.
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Affiliation(s)
- Xin Zhang
- Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Hui-Xian Li
- Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Yi-Ran Chen
- Department of Gynecologic Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Bao-Na Wang
- Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Hui Zheng
- Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
| | - Tao Yan
- Department of Anesthesiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
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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] [Download PDF] [Figures] [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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Ogura K, Ichijima R, Ikehara H, Sugita T, Yamaguchi D, Nagata Y, Esaki M, Minoda Y, Ono H, Hotta K, Kiriyama S, Sumiyoshi T, Kanmura Y. Comparison of remimazolam and midazolam for sedation during colonoscopy in Japanese patients: A propensity score matching analysis. DEN OPEN 2025; 5:e412. [PMID: 39050143 PMCID: PMC11266431 DOI: 10.1002/deo2.412] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 05/30/2024] [Revised: 07/01/2024] [Accepted: 07/06/2024] [Indexed: 07/27/2024]
Abstract
Objectives To compare the efficacy and safety of sedation with midazolam and remimazolam for colorectal endoscopy. Methods This single-center, two-arm, post-hoc analysis of the REM-IICTJP01 study investigated the efficacy and safety of remimazolam for gastrointestinal endoscopic sedation. We enrolled 40 and 208 patients who underwent colonoscopy under remimazolam and midazolam sedation, respectively, during the same period. The primary outcome was the time from the end of the colonoscopy until discharge. The secondary outcomes included the time from the end of the colonoscopy until awakening, dosage, and adverse events. Propensity score matching was employed to eliminate the effect of confounding factors. Results Thirty-seven patients in each group were matched. After propensity matching, the time to awakening after colonoscopy was 28.0 (13.0-37.0) min in the midazolam group and 0 (0-0) min in the remimazolam group; moreover, the time till discharge was 40.0 (35.0-46.5) min in the midazolam group and 0 (0-5.0) min in the remimazolam group, both of which were significantly shorter in the remimazolam group (p < 0.01). The number of additional doses was 0 (0-0) and 2 (1-3) in the midazolam and remimazolam groups, respectively. The total dose was 2.0 (2.0-3.5) and 6.0 (5.0-7.0) mg in the midazolam and remimazolam groups, respectively. Conclusions Remimazolam yielded significantly faster times to awakening and discharge safely compared to midazolam.
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Affiliation(s)
- Kanako Ogura
- Department of Medicine Nihon University School of MedicineDivision of Gastroenterology and HepatologyTokyoJapan
- Department of GastroenterologyNagata Surgery and Gastroenterological ClinicTokyoJapan
| | - Ryoji Ichijima
- Department of Medicine Nihon University School of MedicineDivision of Gastroenterology and HepatologyTokyoJapan
- Department of GastroenterologyKiriyama ClinicGunmaJapan
| | - Hisatomo Ikehara
- Department of Medicine Nihon University School of MedicineDivision of Gastroenterology and HepatologyTokyoJapan
- Department of GastroenterologyInternal MedicineKitasato University School of MedicineKanagawaJapan
| | - Tomomi Sugita
- Department of Medicine Nihon University School of MedicineDivision of Gastroenterology and HepatologyTokyoJapan
| | - Daisuke Yamaguchi
- Department of GastroenterologyNational Hospital Organization Ureshino Medical CenterSagaJapan
| | - Yasuhiko Nagata
- Department of GastroenterologyNagata Surgery and Gastroenterological ClinicTokyoJapan
| | - Mitsuru Esaki
- Department of Medicine and Bioregulatory ScienceGraduate School of Medical SciencesKyushu UniversityFukuokaJapan
| | - Yosuke Minoda
- Department of Medicine and Bioregulatory ScienceGraduate School of Medical SciencesKyushu UniversityFukuokaJapan
| | - Hiroyuki Ono
- Division of EndoscopyShizuoka Cancer CenterShizuokaJapan
| | - Kinichi Hotta
- Division of EndoscopyShizuoka Cancer CenterShizuokaJapan
| | | | | | - Yuichi Kanmura
- Department of AnesthesiologyFujimoto General HospitalMiyazakiJapan
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Pingel L, Maagaard M, Tvarnø CD, Sorenson S, Bukhari S, Andersen LPK, Andersen JH, Mathiesen O. Remimazolam for procedural sedation: A systematic review with meta-analyses and trial sequential analyses. Eur J Anaesthesiol 2025; 42:298-312. [PMID: 39905818 DOI: 10.1097/eja.0000000000002126] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2024] [Accepted: 12/30/2024] [Indexed: 02/06/2025]
Abstract
BACKGROUND Midazolam and propofol are frequently used for procedural sedation. Remimazolam may provide a more controllable sedation with fewer adverse effects. OBJECTIVE To assess the sedation success rate and respiratory and cardiovascular complications of remimazolam versus placebo and other sedatives in adults undergoing procedural sedation. DESIGN A systematic review of randomised controlled trials (RCTs) with meta-analyses, trial sequential analyses (TSA), and GRADE evaluations of the certainty of evidence. DATA SOURCES We searched Medline, Embase, CENTRAL, BIOSIS, CINAHL, and Web of Science Core Collection from their inception to 22 June 2024. ELIGIBILITY CRITERIA RCTs allocating participants undergoing procedural sedation to remimazolam versus placebo or any active comparator. RESULTS We included 63 trials randomising 13 953 participants. All included trial results were judged to be at high risk of bias. The sedation success rate was similar with remimazolam versus active comparators, relative risk (RR) 1.04, [97.5% confidence interval (CI), 0.96 to 1.14; TSA-adjusted CI, 0.95 to 1.18], P = 0.26, GRADE: very low. Subgroup analyses indicated that remimazolam versus midazolam increased sedation success rate, while the risks were similar with remimazolam versus comparators. Remimazolam versus active comparators decreased the risk of respiratory complications, RR 0.47, (97.5% CI, 0.36 to 0.61; TSA-adjusted CI, 0.35 to 0.61), P < 0.01; and cardiovascular complications, RR 0.46, (97.5% CI, 0.37 to 0.56; TSA-adjusted CI, 0.38 to 0.57), P < 0.01. Subgroup analyses indicated that remimazolam versus propofol reduced respiratory and cardiovascular complications, while the risks were similar versus midazolam. CONCLUSION Remimazolam seems to provide a similar sedation success rate as other active comparators (propofol, ciprofol, midazolam, dexmedetomidine, etomidate), although subgroup analyses indicated that remimazolam increased sedation success rate compared to midazolam. Remimazolam compared to propofol may decrease the risk of respiratory and cardiovascular complications. The certainty of the evidence was very low to low, and firm conclusions could not be drawn.
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Affiliation(s)
- Lasse Pingel
- From the Centre for Anaesthesiological Research, Department of Anaesthesiology, Zealand University Hospital, Køge (LP, MM, CDT, SS, SB, LPKA, JHA, OM) and Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark (LPKA, OM)
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11
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Ma D, Li L, Han F, Xu J, Zhang C. Evaluation of deep sedation effects and respiratory aspects of remimazolam besylate in elderly patients undergoing fiberoptic bronchoscopy. Front Med (Lausanne) 2025; 12:1543866. [PMID: 40224634 PMCID: PMC11986998 DOI: 10.3389/fmed.2025.1543866] [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: 01/10/2025] [Accepted: 03/13/2025] [Indexed: 04/15/2025] Open
Abstract
Background The geriatric population, especially individuals over 65 years old with comorbidities classified by the ASA (American Society of Anesthesiologists) grading system, requires careful sedation management during flexible bronchoscopy (FB) to reduce the heightened risks of complications. Hypoxemia is a particularly critical concern in this demographic, leading to considerable morbidity, mortality, and increased healthcare costs. This study focuses on comparing the incidence of sedation-related hypoxemia and other adverse events between remimazolam besylate and propofol during FB procedures, aiming to enhance patient safety and optimize sedation practices in this vulnerable population. Methods This prospective observational cohort study compared the incidence of hypoxemia and sedation-related adverse events between remimazolam besylate and propofol in 69 elderly patients (ASA I-III). Rigorous inclusion/exclusion criteria, clinical monitoring, and alongside comprehensive monitoring of clinical parameters and statistical analyses to ensure the validity of the results. Results Hypoxemia occurred in 44.90% overall, with significantly lower incidence in remimazolam besylate cohort (29.42% vs. 60.00%; OR = 2.10, 95% CI 1.18-3.74, p = 0.017). Recovery to full alertness was prolonged with remimazolam (median 15[12.5-20] vs. 8[5.5-10] min; p < 0.001). A trend toward reduced hypotension was observed (17.65% vs. 37.14%, p = 0.0699), with no other significant safety differences. Conclusion Remimazolam besylate demonstrates superior safety for elderly FB sedation, significantly reducing hypoxemia risk and accelerating recovery. These findings support its preferential use in geriatric sedation protocols, warranting further investigation to optimize clinical implementation strategies.
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Affiliation(s)
- Dongmei Ma
- Department of Anesthesiology, the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China
| | - Li Li
- Department of Anesthesiology, the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China
| | - Fuyi Han
- Department of Anesthesiology, the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China
| | - Jianhong Xu
- Department of Anesthesiology, the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China
| | - Cheng Zhang
- Department of Urology, the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, Zhejiang, China
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12
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Huang XD, Xu L, Zheng CH, Chen MM, Shou HY, Zhou ZF. Effect of Fentanyl on Remimazolam-Induced Sedation in Female Patients Undergoing Hysteroscopic Surgery: A Randomized Controlled Trial. Drug Des Devel Ther 2025; 19:1393-1401. [PMID: 40034404 PMCID: PMC11874992 DOI: 10.2147/dddt.s504189] [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: 11/15/2024] [Accepted: 02/21/2025] [Indexed: 03/05/2025] Open
Abstract
Purpose Previous studies have reported the recommended dosage of remimazolam alone for achieving loss of consciousness (LoC). However, the effect of analgesics on the dosage of remimazolam for successful sedation remains unclear. This study evaluated the impact of fentanyl on the effective dose of remimazolam-induced sedation in female patients undergoing elective hysteroscopic surgery. Patients and Methods Two hundred female patients were randomly allocated into two groups, receiving with or without fentanyl (1ug/kg) during anesthetic induction. Within each group, patients were randomized to receive one of four doses (0.1, 0.2, 0.3, and 0.4 mg/kg) of remimazolam for sedation. Modified Observer's Assessment of Alertness/Sedation (MOAA/S) was evaluated during anesthetic induction. Success was defined when the patient did not respond to painful trapezius squeeze and no requirement for rescue doses. Estimate of ED50 and ED95 with 95% confidence interval (CI) was performed by probit regression. Results The ED50 and ED95 values of remimazolam for patients receiving fentanyl (1 ug/kg) were 0.097 (95% CI, 0.072-0.120) mg/kg and 0.254 (95% CI, 0.203-0.345) mg/kg, respectively. For patients not receiving fentanyl, the ED50 and ED95 values of remimazolam were 0.181 (95% CI, 0.149-0.215) mg/kg and 0.475 (95% CI, 0.377-0.687) mg/kg, respectively. The estimated relative median potency of remimazolam in patients, with and without fentanyl administration, was determined to be 0.534 (95% CI, 0.327-0.737). Conclusion The administration of fentanyl reduced the effective dose of remimazolam-induced sedation by 50% in female patients undergoing elective hysteroscopic surgery. The recommended ED95 dose for remimazolam-induced sedation was 0.254 mg/kg under the condition of this study. Trial Number and Registry Url ChiCTR2400079842; https://www.chictr.org.cn/showproj.html?proj=216480: HUANG, Date of registration: January 15, 2024.
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Affiliation(s)
- Xiao-Dong Huang
- Department of Anesthesiology, Hangzhou Women’s Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People’s Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People’s Republic of China
| | - Lan Xu
- Department of Anesthesiology, Affiliated Xiaoshan Hospital, Hangzhou Normal University, Hangzhou, 311202, People’s Republic of China
| | - Cai-Hong Zheng
- Department of Anesthesiology, Hangzhou Women’s Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People’s Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People’s Republic of China
| | - Min-Min Chen
- Department of Anesthesiology, Hangzhou Women’s Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People’s Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People’s Republic of China
| | - Hong-Yan Shou
- Department of Anesthesiology, Hangzhou Women’s Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People’s Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People’s Republic of China
| | - Zhen-Feng Zhou
- Department of Anesthesiology, Hangzhou Women’s Hospital (Hangzhou Maternity and Child Health Care Hospital, Hangzhou First People’s Hospital Qianjiang New City Campus, Zhejiang Chinese Medical University), Hangzhou, 310008, People’s Republic of China
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El‐Boghdadly K, Desai N, Jones JB, Elghazali S, Ahmad I, Sneyd JR. Sedation for awake tracheal intubation: A systematic review and network meta-analysis. Anaesthesia 2025; 80:74-84. [PMID: 39468765 PMCID: PMC11617133 DOI: 10.1111/anae.16452] [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] [Accepted: 09/19/2024] [Indexed: 10/30/2024]
Abstract
BACKGROUND Different sedation regimens have been used to facilitate awake tracheal intubation, but the evidence has not been synthesised robustly, particularly with respect to clinically important outcomes. We conducted a systematic review and network meta-analysis to determine the sedation techniques most likely to be associated with successful tracheal intubation, a shorter time to successful intubation and a lower risk of arterial oxygen desaturation. METHODS We searched for randomised controlled trials of patients undergoing awake tracheal intubation for any indication and reporting: overall tracheal intubation success rate; tracheal intubation time; incidence of arterial oxygen desaturation; and other related outcomes. We performed a frequentist network meta-analysis for these outcomes if two or more sedation regimens were compared between included trials. We also performed a sensitivity analysis excluding trials with a high risk of bias. RESULTS In total, 48 studies with 2837 patients comparing 33 different regimens were included. Comparing overall awake tracheal intubation success rates (38 studies, 2139 patients), there was no evidence suggesting that any individual sedation regimen was superior. Comparing times to successful tracheal intubation (1745 patients, 24 studies), any sedation strategy was superior to placebo. When we excluded trials with a high risk of bias, we found no evidence of a difference between any interventions for time to successful tracheal intubation. Thirty-one studies (1753 patients) suggested that dexmedetomidine and magnesium sulphate were associated with a reduced risk of arterial oxygen desaturation compared with other interventions, but excluding trials with a high risk of bias suggested no relevant differences between interventions. The quality of evidence for each of our outcomes was low. CONCLUSIONS To maximise effective and safe awake tracheal intubation, optimising oxygenation, topical airway anaesthesia and procedural performance may have more impact than any given sedation regimen.
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Affiliation(s)
- Kariem El‐Boghdadly
- Department of AnaesthesiaGuy's and St Thomas' NHS Foundation TrustLondonUK
- King's College LondonLondonUK
| | - Neel Desai
- Department of AnaesthesiaGuy's and St Thomas' NHS Foundation TrustLondonUK
- King's College LondonLondonUK
| | | | | | - Imran Ahmad
- Department of AnaesthesiaGuy's and St Thomas' NHS Foundation TrustLondonUK
- King's College LondonLondonUK
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Kemp MC, Patel RA, Smith JV, McCoy NC. Hemodynamic Preservation Using Remimazolam in a Heart Failure Parturient Undergoing a Dilation and Curettage: A Case Report. A A Pract 2025; 19:e01897. [PMID: 39749946 DOI: 10.1213/xaa.0000000000001897] [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: 01/04/2025]
Abstract
We report a case of a parturient with severe cardiac disease requiring elective termination of pregnancy. The patient underwent successfully monitored anesthesia care using remimazolam for dilation and curettage. The patient remained hemodynamically stable and appropriately sedated while achieving optimal procedural conditions. Remimazolam is an ultrashort acting benzodiazepine that is being used with increasing frequency in short procedures requiring sedation. Patients with complex cardiac comorbidities undergoing surgical procedures may receive maximum benefit from this novel medication due to its stable hemodynamic profile and rapid metabolism.
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Affiliation(s)
- Megan C Kemp
- From the Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina, Charleston, South Carolina
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15
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Funes-Ferrada R, Yu Lee-Mateus A, Vaca-Cartagena BF, Valdes-Camacho S, Barrios-Ruiz A, Garza-Salas A, Robertson KS, Fernandez-Bussy S, Chadha RM, Abel MD, Scott CL, Abia-Trujillo D. Sedation during dynamic bronchoscopy for expiratory central airway collapse: Which is the ideal protocol? Respir Med 2025; 236:107904. [PMID: 39638010 DOI: 10.1016/j.rmed.2024.107904] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/13/2024] [Revised: 11/05/2024] [Accepted: 12/01/2024] [Indexed: 12/07/2024]
Abstract
OBJECTIVE To compare sedation protocols for dynamic bronchoscopy (DB) in the evaluation of expiratory central airway collapse (ECAC). MATERIALS AND METHODS This observational study included adult patients (≥18 years) referred to Mayo Clinic, Jacksonville, FL, from March 2023 to July 2024, for suspected ECAC. Patients were grouped based on sedation protocols: propofol (Protocol 1), remimazolam (Protocol 2), and remimazolam/fentanyl (Protocol 3). The primary outcome was the quality of assessment during DB, rated on a 4-point Likert scale (1 = poor, 4 = excellent). Secondary outcomes included anesthesia duration and post-anesthesia care unit (PACU) length of stay. Statistical analyses included Fisher's exact test, ordinal logistic regression, and Kruskal-Wallis tests. RESULTS Seventy-three patients met the inclusion criteria. Overall, DB quality of assessment was significantly associated with sedation protocol (P=0.01 Ordinal regression results suggest that protocol 3 (remimazolam/fentanyl) may be comparable to protocol 1 (propofol) (OR0.40, 95%CI 0.12-1.33, P = 0.13), with both showing a tendency for better performance than protocol 2 (remimazolam) (OR0.14, 95%CI 0.04-0.46 P=0.002 vs protocol 3; OR0.35, 95%CI 0.09-0.29 P=0.115 vs protocol 1). No significant differences were found in PACU length of stay among the three protocols (P = 0.13). No post-procedural complications were reported. CONCLUSION Protocol 3 (remimazolam/fentanyl) demonstrated significantly higher odds of achieving a better quality of assessment compared to Protocol 2 (remimazolam) and showed comparable performance to Protocol 1 (propofol). These findings suggest that remimazolam/fentanyl is an effective sedation option for DB, providing improved assessment quality without increasing PACU stay. Larger prospective studies are necessary to confirm these results.
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Affiliation(s)
- Rodrigo Funes-Ferrada
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA.
| | | | | | - Sofia Valdes-Camacho
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA
| | - Alanna Barrios-Ruiz
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA
| | - Ana Garza-Salas
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA; Western Michigan University, Homer Stryker MD School of Medicine, USA
| | - Kelly S Robertson
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA
| | | | - Ryan M Chadha
- Department of Anesthesiology, Mayo Clinic, Jacksonville, FL, USA
| | - Martin D Abel
- Department of Anesthesiology, Mayo Clinic, Jacksonville, FL, USA
| | - Courtney L Scott
- Department of Anesthesiology, Mayo Clinic, Jacksonville, FL, USA
| | - David Abia-Trujillo
- Division of Pulmonary, Allergy and Sleep Medicine, Mayo Clinic, Jacksonville, FL, USA
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Philip AB, Brohan J, Goudra B. The Role of GABA Receptors in Anesthesia and Sedation: An Updated Review. CNS Drugs 2025; 39:39-54. [PMID: 39465449 PMCID: PMC11695389 DOI: 10.1007/s40263-024-01128-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/18/2024] [Indexed: 10/29/2024]
Abstract
GABA (γ-aminobutyric acid) receptors are constituents of many inhibitory synapses within the central nervous system. They are formed by 5 subunits out of 19 various subunits: α1-6, β1-3, γ1-3, δ, ε, θ, π, and ρ1-3. Two main subtypes of GABA receptors have been identified, namely GABAA and GABAB. The GABAA receptor (GABAAR) is formed by a variety of combinations of five subunits, although both α and β subunits must be included to produce a GABA-gated ion channel. Other subunits are γ, δ, ε, π, and ϴ. GABAAR has many isoforms, that dictate, among other properties, their differing affinities and conductance. Drugs acting on GABAAR form the cornerstone of anesthesia and sedation practice. Some such GABAAR agonists used in anesthesia practice are propofol, etomidate, methohexital, thiopental, isoflurane, sevoflurane, and desflurane. Ketamine, nitrous oxide, and xenon are not GABAR agonists and instead inhibit glutamate receptors-mainly NMDA receptors. Inspite of its many drawbacks such as pain in injection, quick and uncontrolled conversion from sedation to general anesthesia and dose-related cardiovascular depression, propofol remains the most popular GABAR agonist employed by anesthesia providers. In addition, being formulated in a lipid emulsion, contamination and bacterial growth is possible. Literature is rife with newer propofol formulations, aiming to address many of these drawbacks, and with some degree of success. A nonemulsion propofol formulation has been developed with cyclodextrins, which form inclusion complexes with drugs having lipophilic properties while maintaining aqueous solubility. Inhalational anesthetics are also GABA agonists. The binding sites are primarily located within α+/β- and β+/α- subunit interfaces, with residues in the α+/γ- interface. Isoflurane and sevoflurane might have slightly different binding sites providing unexpected degree of selectivity. Methoxyflurane has made a comeback in Europe for rapid provision of analgesia in the emergency departments. Penthrox (Galen, UK) is the special device designed for its administration. With better understanding of pharmacology of GABAAR agonists, newer sedative agents have been developed, which utilize "soft pharmacology," a term pertaining to agents that are rapidly metabolized into inactive metabolites after producing desired therapeutic effect(s). These newer "soft" GABAAR agonists have many properties of ideal sedative agents, as they can offer well-controlled, titratable activity and ultrashort action. Remimazolam, a modified midazolam and methoxycarbonyl-etomidate (MOC-etomidate), an ultrashort-acting etomidate analog are two such examples. Cyclopropyl methoxycarbonyl metomidate is another second-generation soft etomidate analog that has a greater potency and longer half-life than MOC-etomidate. Additionally, it might not cause adrenal axis suppression. Carboetomidate is another soft analog of etomidate with low affinity for 11β-hydroxylase and is, therefore, unlikely to have clinically significant adrenocortical suppressant effects. Alphaxalone, a GABAAR agonist, is recently formulated in combination with 7-sulfobutylether-β-cyclodextrin (SBECD), which has a low hypersensitivity profile.
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Affiliation(s)
| | | | - Basavana Goudra
- Department of Anesthesiology, Jefferson Surgical Center Endoscopy, Sidney Kimmel Medical College, Jefferson Health, 111 S 11th Street, #7132, Philadelphia, PA, 19107, USA.
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Xue X, Ma X, Zhao B, Liu B, Zhang J, Li Z, Li H, Liu X, Zhao S. The impact of remimazolam compared to propofol on postoperative delirium: a systematic review and meta-analysis. Minerva Anestesiol 2025; 91:70-79. [PMID: 39846861 DOI: 10.23736/s0375-9393.24.18338-1] [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: 01/24/2025]
Abstract
INTRODUCTION The administration of benzodiazepines has been linked to the occurrence of postoperative delirium (POD) among patients undergoing surgery. In this review, we aim to appraise the current controversy regarding the role of remimazolam in POD. EVIDENCE ACQUISITION A systematic review and meta-analysis of randomized controlled trials was conducted to examine the effects of remimazolam administration on postoperative delirium compared to propofol from inception to April 2024. We conducted a comprehensive search of PubMed, EMBASE, Cochrane Library, Web of Science, Wanfang, and ZhiWang Chinese databases. In the fixed-effects and random-effects statistical models, pooled risk ratios (RRs) or mean differences, 95% CIs, and P values were estimated for endpoints. The trial sequential analysis was used for sensitivity analysis. EVIDENCE SYNTHESIS Among the 479 records screened, 11 randomized controlled trials with 1682 patients were eligible for inclusion. POD did not differ between groups (RR,0.82; 95% CI 0.53-1.26; P=0.36; df=10; I2=42%). There were no statistically significant differences between groups in the incidence of nausea and vomiting, hypoxemia, and length of stay. However, remimazolam had a lower incidence of hypotension and bradycardia than propofol. Analyses of subgroups did not reveal a difference in delirium based on the type of surgery, assessment timing, or definition of cognitive impairment. This result has been supported by the trial sequential analysis. CONCLUSIONS Based on the available evidence, perioperative remimazolam administration is not associated with a significant rise in the incidence of POD.
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Affiliation(s)
- Xiaoming Xue
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Xiangzheng Ma
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Bing Zhao
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Bo Liu
- Department of Tumor Surgery, Second Hospital of Hebei Medical University, Shijiazhuang, China
| | - Jiaqi Zhang
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Zhao Li
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Huizhou Li
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Xin Liu
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China
| | - Shuang Zhao
- Department of Anesthesiology, Third Hospital of Hebei Medical University, Shijiazhuang, China -
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Zhao J, Yu T, He R, Li M, Xia W, Lu Y. Effects of remimazolam and surgery on cognition in a tibia fracture mouse model. Int Immunopharmacol 2024; 143:113464. [PMID: 39486180 DOI: 10.1016/j.intimp.2024.113464] [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: 07/04/2024] [Revised: 10/03/2024] [Accepted: 10/19/2024] [Indexed: 11/04/2024]
Abstract
BACKGROUND To investigate the effects of remimazolam and surgery on cognitive function and neuropathology. METHODS We performed intramedullary pin fixation of tibial fractures in wild-type male (12-13-week-old) C57BL/6J mice under intraperitoneal anesthesia with remimazolam. Age-matched wild-type control mice received either saline or remimazolam without surgery. Training was performed 1 h before surgery, and the open field test was performed on the third postoperative day, in addition to trace fear conditioning on the third versus the seventh day and the Y maze test on the fourth versus the eighth day. Phosphorylated tau (P-TAU) protein levels in hippocampal tissue, microglial activation, dendritic spine density in neuronal cells, and interleukin-6 (IL-6) levels were determined. RESULTS We detected no significant differences in locomotor ability among the three groups in the open field test on the third postoperative day; however, on the conditioned fear test or in the Y-maze, the cognitive related performance of the mice in the surgery group was significantly worse than that of the control group and the remimazolam group. However, there were no differences among the three groups in the behavioural experiments on the seventh and eighth days. In addition, mice in the surgery group had higher levels of P-TAU in their hippocampal tissue, more microglial activation, more significant changes in neuronal dendritic spine density, and higher levels of IL-6 in their hippocampal tissue compared with mice in the other two groups. CONCLUSIONS The cognitive dysfunction and neuropathological changes produced by remimazolam-based surgery are mainly of surgical origin and are not related to the use of remimazolam, a general anesthetic agent.
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Affiliation(s)
- Jianhui Zhao
- Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
| | - Tingting Yu
- Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
| | - Ruilin He
- Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
| | - Mingde Li
- Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China
| | - Weiyi Xia
- Department of Vascular Surgery, James Cook University Hospital, South Tees NHS Trust, Middlesbrough, UK.
| | - Yao Lu
- Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China; Ambulatory Surgery Center, the First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.
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Wu X, Zhang L, Zhou Z, Qi L, Liu Y, Du X, Ma L, Ji X. The Efficacy and Safety Profile of Balanced Propofol Sedation for Bronchoscopy. Ther Clin Risk Manag 2024; 20:849-860. [PMID: 39691941 PMCID: PMC11649497 DOI: 10.2147/tcrm.s495253] [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: 09/08/2024] [Accepted: 12/03/2024] [Indexed: 12/19/2024] Open
Abstract
Purpose We conducted a prospective, real-world study to evaluate the efficacy and safety of balanced propofol sedation (BPS) in bronchoscopy and identify an advantageous sedation regimen for such procedures. Patients and Methods The participants were placed in four groups based on their sedation regimen (exposure factor): the M-S group (midazolam + sufentanil for traditional sedation), R-S group (remimazolam + sufentanil for traditional sedation), M-S-P group (midazolam + sufentanil + propofol for BPS), and R-S-P group (remimazolam + sufentanil + propofol for BPS). The primary outcomes included satisfaction metrics (satisfaction of the patients, endoscopic physicians, and nurses) and follow-up questionnaires. The secondary outcomes included time metrics (induction time, recovery time, and discharge time), dosage metrics (induction dose, maintenance dose, and total dose of each sedative), completion rate of sedation, intraprocedural dose, and frequency of lidocaine spray in the airway, and incidence of adverse reactions. Results In total, 418 subjects were included in this study. Compared to traditional sedation, both BPS groups significantly increased the satisfaction of patients, endoscopic physicians, and nurses (P < 0.05) and reduced the incidence of intraprocedural wakefulness (P < 0.05). Additionally, induction and recovery of the BPS group were rapid, with high sedation completion rates and no increase in the incidence of intraprocedural and postprocedural adverse reactions (P < 0.05). The RSP group was better than the MSP group in terms of various time metrics and postprocedural adverse reactions. Conclusion BPS can be safely and effectively applied during bronchoscopy, with remimazolam and sufentanil combined with a small dose of propofol being an optimal medication regimen.
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Affiliation(s)
- Xinyu Wu
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Lina Zhang
- Department of Anesthesiology, Qingdao Municipal Hospital, Qingdao, Shandong, People’s Republic of China
| | - Zangong Zhou
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Lijie Qi
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Yinhuan Liu
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Xuebin Du
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Lixia Ma
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
| | - Xiangyu Ji
- Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of China
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Yang X, Yang Y, Miao G, Yang C, Liu L, Lei X. Safety and efficacy of remimazolam in mechanical ventilation in the ICU: a protocol for systematic evaluation and meta-analysis. BMJ Open 2024; 14:e091172. [PMID: 39658293 PMCID: PMC11647322 DOI: 10.1136/bmjopen-2024-091172] [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: 07/14/2024] [Accepted: 10/25/2024] [Indexed: 12/12/2024] Open
Abstract
INTRODUCTION Remimazolam is a novel ultra-short-acting benzodiazepine that allosterically modulates γ-aminobutyric acid type A receptors to induce sedative effects. Remimazolam was approved by China for procedural sedation in 2020. Intensive care unit (ICU) patients frequently exhibit impaired liver and renal function as well as haemodynamic instability; thus, the pharmacokinetic properties of remimazolam may offer advantages for ICU sedation. A comprehensive evaluation of the relevant studies warrants further discussion. This systematic review aims to compare the efficacy and safety of the novel intravenous anaesthetic remimazolam with that of commonly used anaesthetics in the ICU. METHODS AND ANALYSIS The following databases will be searched: Embase, Cochrane Library, PubMed, MEDLINE, Web of Science, CNKI and WanFang to retrieve relevant randomised controlled trials (RCTs). This protocol was developed by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols 2020. RCTs about the use of remimazolam for sedation during ICU mechanical ventilation will be included. Two investigators will independently screen articles and extract data according to predefined inclusion and exclusion criteria. Following a qualitative evaluation of each study, data analysis will be conducted using Review Manager 5.4 software. The planned start and end dates for the study were placed on 1 June 2024 and 31 October 2024, respectively. ETHICS AND DISSEMINATION This protocol for the systematic evaluation and meta-analysis does not involve individual patient data; thus, ethical approval is not required. This will be the first meta-analysis to assess the sedative efficacy and safety of remimazolam in the ICU and to provide evidence to inform clinical decision-making. The findings will be disseminated through conference presentations and publications in peer-reviewed journals relevant to the field. PROSPERO REGISTRATION NUMBER CRD42024554425.
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Affiliation(s)
- Xuelian Yang
- Department of Intensive Care Unite, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Yulian Yang
- Department of Intensive Care Unite, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Gelan Miao
- Department of Intensive Care Unite, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Chaobing Yang
- Department of Intensive Care Unite, The Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Li Liu
- Department of Anesthesiology, The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
| | - Xianying Lei
- Department of Intensive Care Unite, The Affiliated Hospital of Southwest Medical University, Luzhou, China
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21
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Liu B, Wang P, Liang L, Zhu W, Zhang H. Effect of Remimazolam vs Midazolam on Early Postoperative Cognitive Recovery in Elderly Patients Undergoing Dental Extraction: A Prospective Randomized Controlled Study. Drug Des Devel Ther 2024; 18:5895-5904. [PMID: 39679137 PMCID: PMC11639880 DOI: 10.2147/dddt.s491223] [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: 08/13/2024] [Accepted: 11/09/2024] [Indexed: 12/17/2024] Open
Abstract
Purpose Elderly patients undergoing dental extraction are particularly susceptible to delayed cognitive recovery after sedation. This study aimed to compare the effects of remimazolam and midazolam on early postoperative cognitive recovery in elderly patients undergoing dental extraction. Patients and Methods This was a single-centre randomized controlled study with elderly patients scheduled for receiving dental extraction under sedation of remimazolam (Group R) or midazolam (Group M). The primary outcome was postoperative cognitive recovery, as measured by the Montreal cognitive assessment 5-minute (MoCA 5-minute) 30 min postoperatively (T30). Secondary outcomes included MoCA 5-minute score 1 h postoperatively (T1h), incidence of post-extraction bleeding, intraoperative adverse events, success rate of sedation, time to discharge, and complications. Results 106 patients (53 in each group) were eligible for the study. At T30, MoCA 5-minute score was 25 (IQR 23.5, 27) in Group R, significantly higher than that of 23 (IQR 21, 25) in Group M (P < 0.001). This difference persisted at T1h [27 (IQR 26, 28) vs 26 (IQR 25, 27), P = 0.003]. Group R also exhibited better hemostasis, with a lower post-extraction bleeding rate at T1 (5.67% vs 33.96%, χ2 = 13.36, P < 0.001). Group R showed significantly shorter times to peak sedation after the first dose of medication, awake time, and time to discharge compared to Group M (P < 0.001, P < 0.001, P < 0.001). Conclusion Remimazolam sedation significantly improves early postoperative cognitive recovery, leading to expedited hemostasis and a shorter discharge time.
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Affiliation(s)
- Bing Liu
- State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Anesthesiology, School of Stomatology, The Fourth Military Medical University, Xi’an, Shaanxi, 710032, People’s Republic of China
| | - Peijuan Wang
- State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Anesthesiology, School of Stomatology, The Fourth Military Medical University, Xi’an, Shaanxi, 710032, People’s Republic of China
| | - Lirong Liang
- State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Anesthesiology, School of Stomatology, The Fourth Military Medical University, Xi’an, Shaanxi, 710032, People’s Republic of China
| | - Wei Zhu
- State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Anesthesiology, School of Stomatology, The Fourth Military Medical University, Xi’an, Shaanxi, 710032, People’s Republic of China
| | - Hui Zhang
- State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Department of Anesthesiology, School of Stomatology, The Fourth Military Medical University, Xi’an, Shaanxi, 710032, People’s Republic of China
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22
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Lee K, Choi SH, Kim S, Kim HD, Oh H, Kim SH. Comparison of remimazolam and midazolam for preventing intraoperative nausea and vomiting during cesarean section under spinal anesthesia: a randomized controlled trial. Korean J Anesthesiol 2024; 77:587-595. [PMID: 39376062 PMCID: PMC11637588 DOI: 10.4097/kja.24311] [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: 05/16/2024] [Revised: 09/03/2024] [Accepted: 09/10/2024] [Indexed: 10/09/2024] Open
Abstract
BACKGROUND Preventing intraoperative nausea and vomiting (IONV) is crucial for maternal safety during cesarean section under spinal anesthesia. While midazolam is known to prevent IONV, we hypothesized that remimazolam would be superior due to its minimal hemodynamic effects. We compared the effects of the two drugs on IONV. METHODS Parturients scheduled for cesarean section were randomly assigned to receive either midazolam or remimazolam. They received midazolam 2 mg or remimazolam 5 mg, with additional doses administered upon request. The primary outcome measure was the incidence of newly developed IONV during sedation. Other outcomes included overall IONV, rescue antiemetic use, shivering, hemodynamic variables, sedation scale scores, and satisfaction scores. RESULTS Data from 80 participants were analyzed. Deeper sedation was induced in the remimazolam group (PGroup × Time < 0.001) despite comparable hemodynamic trends between the groups. The incidence of overall IONV was comparable between the two groups (27.5% in the midazolam group vs. 17.5% in the remimazolam group, absolute risk reduction [ARR]: 0.100, 95% CI [-0.082, 0.282], P = 0.284); however, newly developed IONV during sedation was significantly reduced in the remimazolam group (20.0% vs. 5.0%, ARR: 0.150, 95% CI [0.009, 0.291], P = 0.043). The need for rescue antiemetics was also lower in the remimazolam group (15.0% vs. 2.5%, ARR: 0.125, 95% CI [0.004, 0.246], P = 0.048). CONCLUSION Remimazolam significantly reduced the incidence and severity of newly developed IONV compared with midazolam, with minimal impact on hemodynamics, making it a useful sedative option for cesarean section.
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Affiliation(s)
- Kyuho Lee
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Seung Ho Choi
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Sangil Kim
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Hae Dong Kim
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Hyejin Oh
- Department of Anesthesiology and Pain Medicine, MINT Hospital, Seoul, Korea
| | - Seung Hyun Kim
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
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23
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Teixeira MT, Goyal A. Remimazolam. Adv Anesth 2024; 42:131-150. [PMID: 39443046 DOI: 10.1016/j.aan.2024.07.010] [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] [Indexed: 10/25/2024]
Abstract
Remimazolam is a new reversible γ-aminobutyric acid type A agonist benzodiazepine that displays a fast onset of action, short recovery time with a safe cardiopulmonary profile and favorable pharmacokinetics in comparison with other intravenous sedatives.
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Affiliation(s)
- Miguel T Teixeira
- Department of Anesthesiology, Mayo Clinic, 200 1st Street Southwest, Rochester, MN 55905, USA.
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24
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Ortiz-Jaimes G, Kern R. Expiratory Central Airway Collapse, a "Dynamic" Dilemma. Mayo Clin Proc 2024; 99:1864-1866. [PMID: 39631984 DOI: 10.1016/j.mayocp.2024.10.010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2024] [Accepted: 10/18/2024] [Indexed: 12/07/2024]
Affiliation(s)
| | - Ryan Kern
- Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.
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25
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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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26
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Wang D, Cui M, Wu X, Niu M, Yu T, Zhang Y, Yue Y, Wang Q, Xu B, Feng N, Si J. Efficacy and safety of remimazolam tosylate for patients undergoing off-pump coronary artery bypass grafting: a study protocol for a non-inferiority randomised controlled trial in China. BMJ Open 2024; 14:e085519. [PMID: 39542491 PMCID: PMC11575315 DOI: 10.1136/bmjopen-2024-085519] [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: 02/19/2024] [Accepted: 10/29/2024] [Indexed: 11/17/2024] Open
Abstract
INTRODUCTION Maintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG. METHOD AND ANALYSIS This two-armed non-inferiority randomised controlled trial will include 88 patients aged 18-75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach. ETHICS AND DISSEMINATION This study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER ChiCTR.gov.cn: ChiCTR2400079615.
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Affiliation(s)
- Dan Wang
- School of Anaesthesiology, Shandong Second Medical University, Weifang, Shandong, China
| | - Min Cui
- Department of Anaesthesiology, Zibo Maternal and Child Health Hospital, Zibo, Shandong, China
| | - Xue Wu
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Min Niu
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Tianhao Yu
- Department of Anaesthesiology, Binzhou Medical University, Binzhou, Shandong, China
| | - Yuzhu Zhang
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Yifeng Yue
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Qingting Wang
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Boxuan Xu
- School of Anaesthesiology, Shandong Second Medical University, Weifang, Shandong, China
| | - Nianhai Feng
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
| | - Jiguo Si
- Department of Anaesthesiology, Zibo Central Hospital, Zibo, Shandong, China
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27
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Cheng W, Cheng Y, He H, Zhou D, Wang J, Zhang Y, Wang Z. Efficacy and safety of remimazolam tosilate in anesthesia for short otolaryngology surgery. BMC Anesthesiol 2024; 24:407. [PMID: 39528975 PMCID: PMC11552106 DOI: 10.1186/s12871-024-02790-5] [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: 09/21/2024] [Accepted: 11/01/2024] [Indexed: 11/16/2024] Open
Abstract
BACKGROUND Remimazolam tosilate represents the novel ultrashort-acting benzodiazepine drug. This work focused on exploring whether remimazolam tosilate was effective and safe in anesthesia for short otolaryngology surgery in adults, and optimize its medication regimen, thus providing a theoretical basis for its widespread clinical application. METHODS The present unicentric, double-blind, randomized controlled study enrolled altogether 85 otolaryngology surgery patients aged 18-60 years, and they were divided as remimazolam (RM, 42 cases) or midazolam (MD, 43 cases) group. Efficacy outcomes included successful sedation time, sedation effect (Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score), bispectral index values (BIS), and postoperative recovery. The safety outcomes were patient vital signs at each time point (before induction (T0), 2 min and 5 min after trial drug treatment (T1 and T2 separately), during successful intubation (T3), at the end of surgery (T4), during extubation (T5), and at the time of exiting the room (T6)), any adverse reactions (AEs) during perioperative period, and patient satisfaction with anesthesia experience. RESULTS Demographics were not significantly different in both groups (P > 0.05). RM group had significantly decreased successful sedation time relative to MD group (P < 0.05), while increased successful sedation rate (100%) relative to MD group (90.70%, P = 0.116). RM group showed decreased MOAA/S score and BIS value compared with MD group at T1 and T2 (P < 0.05). The spontaneous respiration recovery time and extubation time were not significantly different in both groups (P > 0.05), but RM group exhibited decreased discharge time compared with MD group (P < 0.05). Compared with MD group, the RM group had lower blood pressure (BP) at T3 (P < 0.05); whereas higher heart rate (HR) and respiration rate (RR) at T1 and T2 (P < 0.05). Difference in AEs was not of statistical significance. Finally, RM group exhibited the increased satisfaction of anesthesia experience compared with MD group (P < 0.05). CONCLUSION Remimazolam tosilate is effective on anesthesia for short otolaryngology surgery. Remimazolam shows the rapid onset, stable circulation, fast postoperative recovery, no increase in perioperative AEs, and high satisfaction with anesthesia experience compared with midazolam. TRIAL REGISTRATION https://www.chictr.org.cn/ (ChiCTR2200067123) on 27/12/2022. This study was consistent with CONSORT guidelines.
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Affiliation(s)
- Wen Cheng
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China
| | - Yi Cheng
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China
| | - Hongying He
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China
| | - Dandan Zhou
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China
| | - Jing Wang
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China
| | - Yi Zhang
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
| | - Zhao Wang
- Department of Anesthesiology, the Second Affiliated Hospital of Zunyi Medical University, Zunyi, 563000, Guizhou, China.
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Xie M, Zeng F, Tian Q, Deng H, Tao S. Clinical study on the safety and efficacy of remimazolam in hysteroscopic surgery under general anesthesia in elderly patients. Front Med (Lausanne) 2024; 11:1409233. [PMID: 39574917 PMCID: PMC11578712 DOI: 10.3389/fmed.2024.1409233] [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: 03/29/2024] [Accepted: 10/21/2024] [Indexed: 11/24/2024] Open
Abstract
Objective To evaluate the safety and efficacy of remimazolam in hysteroscopic surgery in elderly patients. Methods Following hysteroscopic surgery under selected general anesthesia, 60 elderly patients ASA (American Society of Anesthesiologists) class II-III, >65 years old were randomly assigned to one of two groups: the R group (remimazolam) or the C group (propofol), each with 30 patients. Sufentanil 0.1 μg/kg was given 5 min before the operation, remimazolam 0.2 mg/kg intravenously in Group R, then 0.5~1 mg/(kg.h) by pump, propofol 2 mg/kg intravenously in group B, and then 4~8 mg/(kg.h) by pump. Maintain BIS (Bispectral index) 40~70, add remimazolam 0.05 mg/kg or propofol 0.5 mg/kg when the patient is in motion, and stop the administration at the end of the operation. Record the patients' HR, MAP, RR, SpO2, PETCO2, and BIS values at entry (T0), before induction administration (T1), 1 min after administration (T2), 5 min after administration (T3), when stopping administration (T4), when awakening (T5), and 1 min after awakening (T6), as well as the onset time after administration, the awakening time, the success rate of sedation, and the number and dose of additional medications. Reactions are adverse (hypotension, hypertension, respiratory depression incidence, injection pain, nausea and vomiting following surgery, etc.). Results The two groups' respective anesthetic success rates were comparable overall. In addition to having a higher BIS value and more extra medications than group C, group R experienced less incidence of respiratory depression, injection pain, and intraoperative hypotension. Conclusion Remimazolam, which is equivalent to propofol in terms of safety and efficacy for older patients undergoing hysteroscopic surgery, should be further promoted and used.
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Affiliation(s)
- Manjie Xie
- Department of Anesthesiology, Changde Hospital, Xiangya School of Medicine, Central South University (The First People's Hospital of Changde City), Changde, China
| | - Fanrui Zeng
- Department of Orthopedic Surgery, Changde Second People's Hospital, Changde, China
| | - Qiao Tian
- Department of Anesthesiology, Changde Hospital, Xiangya School of Medicine, Central South University (The First People's Hospital of Changde City), Changde, China
| | - Huiwei Deng
- Department of Anesthesiology, Changde Hospital, Xiangya School of Medicine, Central South University (The First People's Hospital of Changde City), Changde, China
| | - Shanqing Tao
- Department of Infectious Diseases, Changde Hospital, Xiangya School of Medicine, Central South University (The First People's Hospital of Changde City), Changde, China
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29
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Luo C, Luo R. Unexpected Pneumothorax During Painless Flexible Bronchoscopy Under Remimazolam Sedation: Two Case Reports and a Literature Review. Clin Case Rep 2024; 12:e9560. [PMID: 39559287 PMCID: PMC11570761 DOI: 10.1002/ccr3.9560] [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: 05/26/2024] [Revised: 09/20/2024] [Accepted: 10/10/2024] [Indexed: 11/20/2024] Open
Abstract
The timely recognition of pneumothorax during painless flexible bronchoscopy (PFB) can be challenging. This report describes two consecutive cases of pneumothorax following PFB, both of which were promptly identified and successfully treated. A sudden decrease in heart rate, combined with hypoxemia, is highly effective for detecting pneumothorax in patients undergoing PFB, with subcutaneous emphysema serving as a key auxiliary diagnostic sign. Remimazolam may provide significant clinical benefits in emergency situations during PFB by allowing patients to be quickly awakened to assist with diagnosis.
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Affiliation(s)
- Cong Luo
- Department of AnesthesiologyThe Second Xiangya Hospital, Central South UniversityChangshaHunanChina
- Anesthesiology Research Institute of Central South UniversityChangshaHunanChina
| | - Ru‐Yi Luo
- Department of AnesthesiologyThe Second Xiangya Hospital, Central South UniversityChangshaHunanChina
- Anesthesiology Research Institute of Central South UniversityChangshaHunanChina
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30
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Tobias JD. Clinical experience with remimazolam in pediatric anesthesiology: An educational focused review. Paediatr Anaesth 2024; 34:1095-1106. [PMID: 39016217 DOI: 10.1111/pan.14970] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/26/2024] [Revised: 07/05/2024] [Accepted: 07/08/2024] [Indexed: 07/18/2024]
Abstract
Remimazolam is a novel ultrashort-acting benzodiazepine, which like midazolam, results in sedation, anxiolysis, and amnesia through its agonistic effects on the gamma-amino butyric acid A receptor. As opposed to midazolam, its unique metabolism is via tissue esterases, which results in a rapid elimination with a limited context sensitive half-life and prompt dissipation of its effect when administration is discontinued. Remimazolam received FDA approval for use in adults in 2020. In preliminary and initial clinical trials, its efficacy and safety has been suggested in the adult population, both as a primary agent for procedural sedation or as an adjunct to general anesthesia. There are limited data regarding the use of remimazolam in infants and children and its use in this population remains off label as it does not hold FDA-approval in pediatric-aged patients. This narrative outlines the pharmacologic properties of this unique medication, reviews previous published reports of its role in pediatric-aged patients, and discusses dosing parameters and clinical use in this population.
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Affiliation(s)
- Joseph D Tobias
- Department of Anesthesiology and Pain Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA
- Department of Anesthesiology and Pain Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA
- Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA
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Goudra B, Sundararaman L, Chandar P, Green M. Anesthesia for Bronchoscopy-An Update. J Clin Med 2024; 13:6471. [PMID: 39518611 PMCID: PMC11546567 DOI: 10.3390/jcm13216471] [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: 09/18/2024] [Revised: 10/13/2024] [Accepted: 10/19/2024] [Indexed: 11/16/2024] Open
Abstract
The field of interventional pulmonology has grown immensely and is increasingly recognized as a subspecialty. The new procedures introduced in the last decade pose unique challenges, and anesthesiologists need to readapt to their specific demands. In this review, we extensively discuss the pathophysiology, technical aspects, preprocedural preparation, anesthetic management, and postprocedural challenges of many new procedures such as navigational bronchoscopy, endobronchial valve deployment, and bronchial thermoplasty. Majority of these procedures are performed under general anesthesia with an endotracheal tube. Total intravenous anesthesia with rocuronium as a muscle relaxant seems to be the standard US practice. The easy availability and proven safety and efficacy of sugammadex as a reversal agent of rocuronium has decreased the need for high-dose remifentanil as an agent to avoid muscle relaxants. Additional research is available with regard to the utility of nebulized lidocaine and is discussed. Finally, two newer drugs administered for conscious sedation (typically without the need of an anesthesiologist) are likely to gain popularity in the future. Remimazolam is a new short-acting benzodiazepine with a relatively faster offset of clinical effects. Dexmedetomidine, a selective adrenergic agonist, is increasingly employed in bronchoscopy as a sedative during bronchoscopic procedures.
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Affiliation(s)
- Basavana Goudra
- Department of Anesthesiology and Perioperative Medicine, Thomas Jefferson University, Philadelphia, PA 19107, USA
- Sidney Kimmel Medical College, 111 S 11th Street, #8280, Philadelphia, PA 19107, USA
| | - Lalitha Sundararaman
- Department of Anesthesiology, Brigham and Women’s Hospital, 75 Francis St., Boston, MA 02115, USA
| | - Prarthna Chandar
- Sidney Kimmel Medical College, 111 S 11th Street, #8280, Philadelphia, PA 19107, USA
- Department of Pulmonary, Allergy and Critical Care, Thomas Jefferson University, Philadelphia, PA 19107, USA
| | - Michael Green
- Department of Anesthesiology and Perioperative Medicine, Thomas Jefferson University, Philadelphia, PA 19107, USA
- Sidney Kimmel Medical College, 111 S 11th Street, #8280, Philadelphia, PA 19107, USA
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Wang XL, Dai LL, Li YN, Zhang JW, Qu MC, Zhou YY, Xing N. Comparing Remimazolam and Propofol for Postoperative Anesthesia Satisfaction in Outpatient Gynecological Surgery: A Randomized Clinical Trial. Drug Des Devel Ther 2024; 18:4615-4627. [PMID: 39440139 PMCID: PMC11495188 DOI: 10.2147/dddt.s483029] [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: 06/18/2024] [Accepted: 10/12/2024] [Indexed: 10/25/2024] Open
Abstract
Purpose This study aimed to compare the efficacy of remimazolam and propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery. Patients and Methods This was a single-center, open-label, non-inferiority, randomized clinical trial. Patients aged ≥ 18 years who underwent outpatient gynecological surgery with sedation were enrolled. Participants were randomly assigned to be sedated with remimazolam or propofol. The primary endpoint was the immediate postoperative anesthesia satisfaction score, evaluated through the Iowa Satisfaction with Anesthesia Scale (ISAS). Results 168 patients were randomly allocated to either the remimazolam group (n = 84) or the propofol group (n = 84). The mean (standard deviation) ISAS scores immediately after surgery were 1.7 (0.6) for the remimazolam group and 2.0 (0.7) for the propofol group (difference, -0.2; 97.5% confidence interval [CI]: -0.5 to -0.0; p = 0.02), indicating non-inferiority. The length of post-anesthesia care unit (PACU) stay was longer in the remimazolam group than in the propofol group (27.6 [9.1] min vs 22.4 [7.0] min; difference, 5.2 [95% CI: 2.7 to 7.6] min; p < 0.001). High-intensity injection pain was less frequently observed in the remimazolam group than in the propofol group (3.6% vs 45.2%; difference, -41.7% [95% CI: -54.2% to -29.1%]; p < 0.001). The nausea score was higher in the remimazolam group immediately after surgery than in the propofol group. Pain, nausea, sleep quality, anxiety, and depression scores were higher in the remimazolam group than in the propofol group on postoperative day 1. The incidence of adverse events and other secondary endpoints was comparable between the two groups. Conclusion Remimazolam was non-inferior to propofol regarding postoperative anesthesia satisfaction in patients undergoing outpatient gynecological surgery. Therefore, it should be considered as a new sedation alternative in such procedures.
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Affiliation(s)
- Xu-Lin Wang
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Ling-Ling Dai
- Department of Respiration, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Yan-Na Li
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Jian-Wen Zhang
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Ming-Cui Qu
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Yao-Yao Zhou
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People’s Republic of China
| | - Na Xing
- Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 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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Elmati PR, Nagaradona T, Jagirdhar GSK, Surani S. Remimazolam in intensive care unit: Potential applications and considerations. World J Crit Care Med 2024; 13:96877. [PMID: 39253308 PMCID: PMC11372519 DOI: 10.5492/wjccm.v13.i3.96877] [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: 05/17/2024] [Revised: 06/28/2024] [Accepted: 07/17/2024] [Indexed: 08/30/2024] Open
Abstract
This manuscript explores the potential use of Remimazolam in the intensive care unit (ICU) and critical care units, considering its pharmacological characteristics, clinical applications, advantages, and comparative effectiveness over current sedatives and anesthetics. We reviewed existing PubMed and Google Scholar literature to find relevant studies on Remimazolam in ICU. We created search criteria using a combination of free text words, including Remimazolam, critical care, intensive care, sedation, anesthesia, pharmacokinetics, and pharmacodynamics. Relevant articles published in the English language were analyzed and incorporated. Remimazolam is an ultra-short-acting benzodiazepine derivative promising for sedation and anesthesia. It is a safer option for hemodynamically unstable, elderly, or liver or kidney issues. It also has comparable deep sedation properties to propofol in the ICU. Furthermore, it reduces post-procedural delirium and patient comfort and reduces the need for additional sedatives in pediatric patients. In conclusion, Remimazolam is an excellent alternative to current sedatives and anesthetics in the ICU. Its cost is comparable to that of current medications. Further research on its long-term safety in the ICU and its broader application and incorporation into routine use is necessary.
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Affiliation(s)
- Praveen Reddy Elmati
- Department of Anesthesiology, Saint Clair Hospital, Dover, NJ 07801, United States
| | - Teja Nagaradona
- School of Medicine, St George University, Granada SW17 0BD, West Indies
| | | | - Salim Surani
- Department of Medicine & Pharmacology, Texas A&M University, College Station, TX 77843, United States
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Scheckenbach V, Drexler B. [Remimazolam-Update on basic pharmacologic principles and clinical potential]. DIE ANAESTHESIOLOGIE 2024; 73:617-626. [PMID: 39158735 DOI: 10.1007/s00101-024-01450-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 08/20/2024]
Abstract
In recent years the still relatively new short-acting benzodiazepine remimazolam has been approved and clinically implemented in several countries and regions. Remimazolam is also now approved in the EU and the market launch in Germany is expected in the not too distant future. This is therefore a good point in time to summarize the current evidence for various areas of application, including general anesthesia, sedation and intensive care medicine as well as different dosing schemes.
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Affiliation(s)
- Vera Scheckenbach
- Universitätsklinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Deutschland
| | - Berthold Drexler
- Universitätsklinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen, Hoppe-Seyler-Str. 3, 72076, Tübingen, Deutschland.
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36
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Masui K. Remimazolam: its clinical pharmacology and evolving role in anesthesia and sedation practice. Curr Opin Anaesthesiol 2024; 37:344-351. [PMID: 38841907 DOI: 10.1097/aco.0000000000001384] [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: 06/07/2024]
Abstract
PURPOSE OF REVIEW Remimazolam is a novel benzodiazepine anesthetic/sedative, designed as a rapidly metabolized carboxylic acid. Since its recent launch, the role of remimazolam in modern anesthesia and sedation practice is still evolving. This review aims to outline the clinical pharmacology and clinical utility of remimazolam to elucidate its potential advantages and limitations. RECENT FINDINGS Remimazolam is "short-acting" but not ultra-short-acting compared with propofol based on context-sensitive decrement times. But compared to propofol, the availability of the benzodiazepine antagonist, flumazenil, is considered an advantage, particularly in certain emergency situations such as in patients with difficult airways. However, because flumazenil is shorter acting than remimazolam when remimazolam accumulates or is present in a high concentration, the reappearance of remimazolam sedation may occur after the initial reversal of anesthesia/sedation from flumazenil administration. Although it is beneficial that remimazolam causes less respiratory depression and hypotension than propofol, serious respiratory depression and hypotension can still occur. Remimazolam administration causes minimal or no pain on injection. Remimazolam is associated with less postoperative nausea and vomiting than inhaled anesthetics, but propofol is clearly superior in this regard. The anesthetic/sedative effects may be prolonged by severe hepatic impairment; remimazolam tolerance can occur in long-term benzodiazepine users. SUMMARY Remimazolam may be beneficial to use in procedural sedation and general anesthesia for patients with difficult airways or hemodynamic instability. Further clinical studies with remimazolam are warranted to identify the potential benefits in other settings and patient populations.
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Affiliation(s)
- Kenichi Masui
- Department of Anesthesiology, Yokohama City University School of Medicine, Yokohama, Japan
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37
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Yim S, Choi CI, Park I, Koo BW, Oh AY, Song IA. Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial. Can J Anaesth 2024; 71:1067-1077. [PMID: 38609684 DOI: 10.1007/s12630-024-02735-z] [Citation(s) in RCA: 6] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Revised: 11/24/2023] [Accepted: 12/01/2023] [Indexed: 04/14/2024] Open
Abstract
PURPOSE Maintaining hemodynamic stability during cardiac ablation under general anesthesia is challenging. Remimazolam, a novel ultrashort-acting benzodiazepine, is characterized by maintaining comparatively stable blood pressure and does not influence the cardiac conduction system, which renders it a reasonable choice for general anesthesia for cardiac ablation. We aimed to evaluate whether remimazolam is associated with a decreased incidence of intraoperative hypotension compared with desflurane. METHODS In this single-centre, parallel-group, prospective, single-blind, randomized clinical trial, we randomized patients (1:1) into a remimazolam group (remimazolam-based total intravenous anesthesia) or desflurane group (propofol-induced and desflurane-maintained inhalational anesthesia) during cardiac ablation procedures for arrhythmia. The primary outcome was the incidence of intraoperative hypotensive events, defined as mean arterial pressure of < 60 mm Hg at any period. RESULTS Overall, we enrolled 96 patients between 2 August 2022 and 19 May 2023 (47 and 49 patients in the remimazolam and desflurane groups, respectively). The remimazolam group showed a significantly lower incidence of hypotensive events (14/47, 30%) than the desflurane group (29/49, 59%; relative risk [RR], 0.5; 95% confidence interval [CI], 0.31 to 0.83; P = 0.004). Remimazolam was associated with a lower requirement for bolus or continuous vasopressor infusion than desflurane was (23/47, 49% vs 43/49, 88%; RR, 0.56; 95% CI, 0.41 to 0.76; P < 0.001). No between-group differences existed in the incidence of perioperative complications such as nausea, vomiting, oxygen desaturation, delayed emergence, or pain. CONCLUSIONS Remimazolam was a viable option for general anesthesia for cardiac ablation. Remimazolam-based total intravenous anesthesia was associated with significantly fewer hypotensive events and vasopressor requirements than desflurane-based inhalational anesthesia was, without significantly more complications. STUDY REGISTRATION ClinicalTrials.gov (NCT05486377); first submitted 1 August 2022.
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Affiliation(s)
- Subin Yim
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Chang Ik Choi
- Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
- Department of Anesthesiology and Pain Medicine, Yongin Severance Hospital, Yongin, Republic of Korea
| | - Insun Park
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Bon Wook Koo
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
- Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
| | - Ah Young Oh
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
- Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
| | - In-Ae Song
- Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
- Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
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Shapiro AB, Smith MA, Moshe CT, Frey GT, Chadha RM. Remimazolam As a Sole Sedative Agent for Gastrostomy Tubes Placed in the Interventional Radiology Suite: A Case Series. A A Pract 2024; 18:e01839. [PMID: 39105528 DOI: 10.1213/xaa.0000000000001839] [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: 08/07/2024]
Abstract
Remimazolam is an ultrashort acting intravenous sedative-hypnotic approved for procedural sedation. We report a series of 8 cases of radiographically placed gastrostomy tubes using remimazolam as the sole anesthetic agent. Interventional radiology (IR) gastrostomy tube placement entails anesthetizing often complex patients in a nonoperating room environment. All 8 patients reported here underwent successful gastrostomy tube placement without the need for conversion to general anesthesia. Remimazolam is a feasible option to sedate patients for gastrostomy tube placement in the IR suite.
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Affiliation(s)
- Anna Bovill Shapiro
- From the Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, Florida
- Department of Critical Care Medicine, Mayo Clinic, Jacksonville, Florida
| | - Michael A Smith
- From the Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, Florida
- Department of Critical Care Medicine, Mayo Clinic, Jacksonville, Florida
| | - Christine T Moshe
- From the Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, Florida
| | - Gregory T Frey
- Department of Radiology, Mayo Clinic, Jacksonville, Florida
| | - Ryan M Chadha
- From the Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Jacksonville, Florida
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Deng W, Zeng Z, Liu Q, Deng J, Wang L, Li H, Zhang Y. Effects of Propofol, Low and High Doses of Remimazolam on Hemodynamic and Inflammatory Response in Laparoscopic Surgery. Drug Des Devel Ther 2024; 18:3329-3336. [PMID: 39100225 PMCID: PMC11298169 DOI: 10.2147/dddt.s459885] [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: 02/23/2024] [Accepted: 07/22/2024] [Indexed: 08/06/2024] Open
Abstract
Background This study explored the effects of different doses of remimazolam tosilate (RT) and propofol combined with remifentanil anesthesia on hemodynamic and inflammatory responses in patients undergoing laparoscopic surgery. Subjects and Methods Ninety patients with a BMI of less than 35 kg/m², classified as ASA II-III and scheduled for laparoscopic surgery, were enrolled in this study. Patients were divided into three groups: low-dose RT group (A), high-dose RT group (B), and propofol group (C). The changes in hemodynamic indices such as SBP, DBP, HR, MAP, and inflammatory response indices such as IL-6, SAA, CRP, and PCT, along with extubation time and doses of sufentanil, remifentanil, urapidil, and phenylephrine, were compared among the three groups. Results There were no statistically significant differences in extubation time, doses of sufentanil and remifentanil, or the usage rates and average doses of urapidil and phenylephrine between the three groups. The average dose of phenylephrine in group A was lower than in group B and group C, with a statistically significant difference. There were no statistically significant differences among the groups in SBP, DBP, HR, and MAP from T0 to T2, nor in IL-6, SAA, CRP, or PCT levels. Conclusion Using RT for induction and maintenance of anesthesia in laparoscopic surgery ensures stable hemodynamic and inflammatory responses in patients. Low-dose RT may reduce the usage rate and dose of vasopressors such as phenylephrine during surgery.
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Affiliation(s)
- Wenguang Deng
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Zhiming Zeng
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Qingyan Liu
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Jingjing Deng
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Liyu Wang
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Hui Li
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
| | - Yuenong Zhang
- The Anesthesiology Surgery Center of The Third Affiliated Hospital of Sun Yat-sen University-Yuedong Hospital, Guangdong, People’s Republic of China
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40
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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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Ma HY, Cai YH, Zhong JW, Chen J, Wang Z, Lin CY, Wang QQ, Liu HC. The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial. Front Pharmacol 2024; 15:1373006. [PMID: 38983921 PMCID: PMC11231196 DOI: 10.3389/fphar.2024.1373006] [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: 01/19/2024] [Accepted: 06/03/2024] [Indexed: 07/11/2024] Open
Abstract
Background: Remimazolam, a new ultrashort-acting benzodiazepine, is becoming increasingly applied in general anesthesia. This study is designed to investigate the effect of remimazolam-based total intravenous anesthesia and sevoflurane-based inhalation anesthesia on emergence delirium in pediatric tonsillectomy and adenoidectomy. Methods and analysis: This is a monocentric, prospective, randomized, double-blind clinical trial. A total of 90 pediatric patients will be randomized to receive remimazolam-based total intravenous anesthesia (remimazolam group, n = 45) or sevoflurane-based inhalation anesthesia (sevoflurane group, n = 45). The primary outcome will be the incidence of emergence delirium, which will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The secondary outcomes include the extubation time, recovery time, behavior change using the post-hospitalization behavior questionnaire for ambulatory surgery (PHBQ-AS), and adverse events. Ethics and dissemination: This study has been approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (2023-K-262-02). Clinical trial registration: ClinicalTrials.gov, identifier NCT06214117.
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Affiliation(s)
- Hong-Yu Ma
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
| | - Yu-Hang Cai
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
| | - John Wei Zhong
- Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, TX, United States
| | - Jia Chen
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
| | - Zhen Wang
- Laboratory Medicine Center, Allergy Center, Department of Transfusion Medicine, Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College, Hangzhou, Zhejiang, China
| | - Chao-Yi Lin
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
| | - Qiao-Qiao Wang
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
| | - Hua-Cheng Liu
- Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Pediatric Anesthesiology, Ministry of Education, Wenzhou Medical University, Wenzhou, Zhejiang, China
- Key Laboratory of Anesthesiology of Zhejiang Province, Wenzhou Medical University, Wenzhou, Zhejiang, China
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Xu H, Wang L, Zhu W, Ren C, Liu G, Liu Y. Comparison of the Safety and Efficacy of Remimazolam Besylate versus Dexmedetomidine for Patients Undergoing Fiberoptic Bronchoscopy: A Prospective, Randomized Controlled Trial. Drug Des Devel Ther 2024; 18:2317-2327. [PMID: 38915861 PMCID: PMC11194170 DOI: 10.2147/dddt.s460949] [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: 01/23/2024] [Accepted: 06/11/2024] [Indexed: 06/26/2024] Open
Abstract
Objective Remimazolam besylate is a novel ultra-short-acting benzodiazepine that is rapidly hydrolyzed to zolpidem propionic acid by tissue lipases. We designed this study to compare the safety and efficacy of remimazolam besylate alfentanil versus dexmedetomidine-alfentanil for fiberoptic bronchoscopy (FB). Methods One hundred and twenty patients undergoing FB into this prospective randomized controlled trial were divided into two groups. The anesthesia induction consisted of 6 mg/kg/h of remimazolam besylate in the RA group and 0.5 μg/kg of dexmedetomidine in the DA group. 1-2 mg/kg/h of remimazolam besylate or 0.2-0.7 µg/kg/h of dexmedetomidine were administered to maintain during FB. The lowest oxygen saturation, success rate of FB, hemodynamics, time metrics, bronchoscopy feasibility, drug dose requirements, patient and bronchoscopist satisfaction scores, occurrence of intraoperative awareness, number of patients willing to repeat FB with the same sedation regimen, and occurrence and severity of adverse events. Results The lowest oxygen saturation during the FB was significantly higher in the RA group (P = 0.001). Compared with the variables in the DA group, peripheral oxygen saturation, systolic blood pressure, and diastolic blood pressure were significantly lower at T2 and T3 in the RA group (P < 0.05). Heart rates were significantly higher from T2 to T4 in the DA group (P < 0.05). More patients experienced bradycardia in the DA group (P = 0.041). Compared with time metrics in the DA group, the induction time, fully-alert time, and recovery room-leaving time were all significantly shorter in the RA group (P < 0.05). The bronchoscopy feasibility scores in the RA group were significantly lower at T2, whereas they were lower at T3 in the DA group (P < 0.05). Conclusion Remimazolam besylate is superior to dexmedetomidine when combined with alfentanil during FB, promoting faster patients' recovery, better operative conditions and respiratory stability with similar rates of occurrence and severity of adverse events.
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Affiliation(s)
- Huiying Xu
- Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, People’s Republic of China
| | - Lizhen Wang
- Department of Tuberculosis, Liaocheng Infectious Disease Hospital, Liaocheng, People’s Republic of China
| | - Wenchao Zhu
- Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, People’s Republic of China
| | - Chunguang Ren
- Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, People’s Republic of China
| | - Guoying Liu
- Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, People’s Republic of China
| | - Yanchao Liu
- Department of Anaesthesiology, Liaocheng People’s Hospital, Liaocheng, People’s Republic of China
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Choi SH, Min KT, Park EK, Park S. Comparison of hypotension incidence between remimazolam and propofol in patients with hypertension undergoing neurosurgery: prospective, randomized, single-blind trial. BMC Anesthesiol 2024; 24:198. [PMID: 38834996 PMCID: PMC11149299 DOI: 10.1186/s12871-024-02578-7] [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: 02/27/2024] [Accepted: 05/27/2024] [Indexed: 06/06/2024] Open
Abstract
BACKGROUND Remimazolam, a newer benzodiazepine that targets the GABAA receptor, is thought to allow more stable blood pressure management during anesthesia induction. In contrast, propofol is associated with vasodilatory effects and an increased risk of hypotension, particularly in patients with comorbidities. This study aimed to identify medications that can maintain stable vital signs throughout the induction phase. METHODS We conducted a single-center, two-group, randomized controlled trial to investigate and compare the incidence of hypotension between remimazolam- and propofol-based total intravenous anesthesia (TIVA). We selected patients aged between 19 and 75 years scheduled for neurosurgery under general anesthesia, who were classified as American Society of Anesthesiologists Physical Status I-III and had a history of hypertension. RESULTS We included 94 patients in the final analysis. The incidence of hypotension was higher in the propofol group (91.3%) than in the remimazolam group (85.4%; P = 0.057). There was no significant difference in the incidence of hypotension among the various antihypertensive medications despite the majority of patients being on multiple medications. In comparison with the propofol group, the remimazolam group demonstrated a higher heart rate immediately after intubation. CONCLUSIONS Our study indicated that the hypotension incidence of remimazolam-based TIVA was comparable to that of propofol-based TIVA throughout the induction phase of EEG-guided anesthesia. Both remimazolam and propofol may be equally suitable for general anesthesia in patients undergoing neurosurgery. TRIAL REGISTRATION Clinicaltrials.gov (NCT05164146).
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Affiliation(s)
- Seung Ho Choi
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
| | - Kyeong Tae Min
- Department of Anesthesiology and Pain Medicine, Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 50-1 Yonsei-Ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
| | - Eun Kyung Park
- Department of Pediatric Neurosurgery, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Sujung Park
- Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
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Smith A, Kalsotra S, Tobias JD. The Use of Remimazolam During Awake Craniotomy for Seizure Foci Resection in Adolescents: A Case Series. J Clin Med Res 2024; 16:319-323. [PMID: 39027811 PMCID: PMC11254310 DOI: 10.14740/jocmr5175] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/09/2024] [Accepted: 05/31/2024] [Indexed: 07/20/2024] Open
Abstract
Remimazolam is a novel benzodiazepine with sedative, anxiolytic, and amnestic properties similar to midazolam. Metabolism by tissue esterases results in a short clinical half-life of 5 - 10 min and a limited context sensitive half-life. We present initial retrospective clinical experience with the use of remimazolam as an intraoperative adjunct to sedation during awake craniotomy in a cohort of three adolescent patients. A remimazolam infusion was added to a combination of dexmedetomidine and remifentanil to deepen the level of sedation during surgical incision, craniotomy, duraplasty, and surgical dissection for exposure of the seizure foci. The remimazolam infusion was discontinued 30 min prior to the planned awake assessments and electrophysiology testing. The patients emerged calmly and were able to follow commands for intraoperative testing. Our anecdotal experience supports the efficacy of remimazolam for awake craniotomy and tumor resection using a standard asleep-awake-asleep technique. We noted adequate sedation, maintenance of spontaneous respiration, rapid awakening, and no limitations to intraoperative neuromonitoring or awake assessment in our three patients.
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Affiliation(s)
- Ashley Smith
- Department of Anesthesiology & Pain Medicine, Nationwide Children’s Hospital, Columbus, OH, USA
- Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA
| | - Sidhant Kalsotra
- Department of Anesthesiology & Pain Medicine, Nationwide Children’s Hospital, Columbus, OH, USA
| | - Joseph D. Tobias
- Department of Anesthesiology & Pain Medicine, Nationwide Children’s Hospital, Columbus, OH, USA
- Department of Anesthesiology & Pain Medicine, The Ohio State University College of Medicine, Columbus, OH, USA
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Seol HY, Hong KS, Jang JG, Moon SM, Kim SH, Cho JY, Yang B, Kim S, Choi CM, Ji W, Ahn JH. A prospective, open-label, randomized clinical trial to evaluate the efficacy and safety of remimazolam in patients undergoing EBUS-TBNA: REST trial design. BMC Pulm Med 2024; 24:243. [PMID: 38760702 PMCID: PMC11100028 DOI: 10.1186/s12890-024-03067-w] [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: 04/11/2024] [Accepted: 05/16/2024] [Indexed: 05/19/2024] Open
Abstract
BACKGROUND Remimazolam is safe and effective for moderate sedation during flexible bronchoscopy, but its safety and efficacy during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains undetermined. The REST trial (NCT06275594) will be a prospective randomized study of remimazolam in patients undergoing EBUS-TBNA with conscious sedation. The primary aim is to evaluate whether remimazolam is safe and effective for moderate sedation during EBUS-TBNA compared to real-world midazolam and on-label midazolam. METHODS The REST trial will recruit 330 patients from four university hospitals with mediastinal lesions suspected of being lung cancer who are eligible for EBUS-TBNA under moderate sedation. The participants will be randomized into groups using remimazolam, real-world midazolam, and on-label midazolam (US prescribing information dosage) to perform EBUS-TBNA for procedural sedation. The primary endpoint will be procedural success using composite measures. DISCUSSION The REST trial will prospectively evaluate the efficacy and safety of remimazolam during EBUS-TBNA under moderate sedation. It will provide information for optimizing sedation modalities and contribute to practical benefits in patients undergoing EBUS-TBNA. TRIAL REGISTRATION ClinicalTrials.gov (NCT06275594). Prospectively registered on 15 February 2024.
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Affiliation(s)
- Hee Yun Seol
- Department of Internal Medicine, Pusan National University School of Medicine, Busan, Republic of Korea
- Division of Pulmonary and Critical Care Medicine, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea
| | - Kyung Soo Hong
- Division of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea
| | - Jong Geol Jang
- Division of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea
| | - Seong Mi Moon
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea
| | - Sun-Hyung Kim
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea
| | - Jun Yeun Cho
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea
| | - Bumhee Yang
- Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea
| | - Seonok Kim
- Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Chang-Min Choi
- Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea
| | - Wonjun Ji
- Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Republic of Korea.
| | - June Hong Ahn
- Division of Pulmonology and Allergy, Department of Internal Medicine, College of Medicine, Yeungnam University and Respiratory Center, Yeungnam University Medical Center, 170 Hyeonchung-Ro, Namgu, Daegu, 42415, Republic of Korea.
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Huang Y, Zheng D, Xu K, Li J, Gu Y, Yin Z, Pan J, Shen J, Lu X, Zhong F, Qiu Y. Randomized, Single-Blind, Comparative Study of Remimazolam Besylate vs Propofol for Facial Plastic Surgery. Aesthet Surg J 2024; 44:NP357-NP364. [PMID: 38340328 DOI: 10.1093/asj/sjae033] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/11/2023] [Revised: 02/01/2024] [Accepted: 02/05/2024] [Indexed: 02/12/2024] Open
Abstract
BACKGROUND Use of local anesthesia and conscious sedation with a combination of a sedative and anesthetic drug during a surgical procedure is an approach designed to avoid intubation, which produces fewer adverse events compared to general anesthesia. In the present study, a comparison was made between the efficacy and safety of remimazolam besylate and propofol for facial plastic surgery. OBJECTIVES The objective was to evaluate the clinical efficacy, comfort, and incidence of adverse events of remimazolam compared with propofol combined with alfentanil in outpatient facial plastic surgery. METHODS In this randomized, single-blind, single-center, comparative study, facial plastic surgery patients were randomly divided into remimazolam-alfentanil (n = 50) and propofol-alfentanil (n = 50) groups for sedation and analgesia. The primary endpoint was the incidence of hypoxemia, while secondary endpoints included efficacy and safety evaluations. RESULTS There were no significant differences regarding the surgical procedure, sedation and induction times, pain and comfort scores, muscle strength recovery, heart rate, respiratory rate, and blood pressure, but the dosage of alfentanil administered to the remimazolam group (387.5 μg) was lower than that for the propofol group (600 μg). The incidence of hypoxemia (P = .046) and towing of the mandibular (P = .028), as well as wake-up (P = .027) and injection pain (P = .008), were significantly higher in the propofol group than the remimazolam group. CONCLUSIONS Remimazolam and propofol had similar efficacies for sedation and analgesia during facial plastic surgery, but especially the incidence of respiratory depression was significantly lower in patients given remimazolam. LEVEL OF EVIDENCE: 2
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Huang B, Li NP, Tan GK, Liang N. Effectiveness and safety of remimazolam combined with alfentanil in hysteroscopic examination: A prospective, randomized, single-blind trial. Medicine (Baltimore) 2024; 103:e37627. [PMID: 38608088 PMCID: PMC11018237 DOI: 10.1097/md.0000000000037627] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2024] [Accepted: 02/26/2024] [Indexed: 04/14/2024] Open
Abstract
BACKGROUND Remimazolam is a novel, ultrashort-acting benzodiazepine. This study aimed to compare the efficacy and safety of remimazolam and propofol for hysteroscopic examination, to determine the optimal dose of remimazolam combined with alfentanil for painless hysteroscopy, and to calculate its median effective dose (ED50). METHODS Step 1: A total of 208 patients undergoing hysteroscopic examination were prospectively included in this study. Patients were randomized into 4 groups: 0.2 mg/kg remimazolam (group A), 0.25 mg/kg remimazolam besylate (group B), 0.3 mg/kg remimazolam (group C), and 2 mg/kg propofol (group D), with 52 patients in each group. One minute after losing consciousness, patients received an intravenous injection of alfentanil at 5 µg/kg, followed by a continuous infusion of alfentanil at 0.5 µg/kg/min. If patients showed frowning, movement, or MOAA/S > 1, sedatives were added: 0.05 mg/kg/dose of remimazolam for groups A, B, and C, and 0.5 mg/kg/dose of propofol for group D. Step 2: Dixon's up-and-down method was used to calculate the ED50 of remimazolam combined with alfentanil during hysteroscopic examination. MAIN RESULTS The sedation success rates of the remimazolam groups were 88.46%, 94.23%, and 98.08%, respectively, compared to 96.15% in the propofol group, with no significant difference (P = .175). MAP in groups A and B was higher than in group D (P < .05), and significantly higher in group C than in group D (P = .0016). SpO2 values in groups A, B, and C were higher than in group D at T2 to T3 (P < .001). HR in groups A, B, and C was significantly higher than in group D (P < .001). The ED50 of remimazolam combined with alfentanil in hysteroscopy was 0.244 mg/kg, 95%CI (0.195-0.22) and ED95 was 0.282 mg/kg, 95%CI (0.261-1.619). CONCLUSION In hysteroscopy, the sedative effect of remimazolam is like that of propofol, with 0.25 mg/kg remimazolam showing better safety and efficacy, and less impact on the respiratory and circulatory systems. Additionally, under the influence of alfentanil, the ED50 of remimazolam in hysteroscopy is 0.244 mg/kg, with no severe adverse reactions observed.
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Affiliation(s)
- Bei Huang
- The Affiliated Nanhua Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China
- The Affiliated Nanhua Hospital, Department of Anesthesiology, Hengyang Medical School, University of Suth China, Hengyang, Hunan, China
| | - Nan-Ping Li
- The Affiliated Nanhua Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China
- The Affiliated Nanhua Hospital, Department of Anesthesiology, Hengyang Medical School, University of Suth China, Hengyang, Hunan, China
| | - Gang-Kai Tan
- The Affiliated Nanhua Hospital, Hengyang Medical School, University of South China, Hengyang, Hunan, China
- The Affiliated Nanhua Hospital, Department of Anesthesiology, Hengyang Medical School, University of Suth China, Hengyang, Hunan, China
| | - Na Liang
- The Affiliated Nanhua Hospital, Department of Anesthesiology, Hengyang Medical School, University of Suth China, Hengyang, Hunan, China
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Chen D, Liao M, Wu XR, Zhao TYM, Sun H. Comparison of efficacy and safety of equivalent doses of remimazolam versus propofol for gastroscopy anesthesia in elderly patients. Sci Rep 2024; 14:7645. [PMID: 38561361 PMCID: PMC10984999 DOI: 10.1038/s41598-024-58294-2] [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: 12/02/2023] [Accepted: 03/27/2024] [Indexed: 04/04/2024] Open
Abstract
Remimazolam, a novel intravenous anesthetic, has been proven to be safe and efficacious in the gastroscopy setting among the elderly. However, reports comparing the effectiveness and safety of using equivalent doses of remimazolam with propofol have not been seen. The aim of this study was to compare the sedation efficacy and safety of the 95% effective doses (ED95) of remimazolam versus propofol combined with sufentanil in the gastroscopy setting among the elderly. In the first step of this two-step study, a modified up-and-down method was used to calculate the ED95 of remimazolam and propofol when combined with 0.1 µg/kg sufentanil in inhibiting body movement of elderly patients undergoing gastroscopy. In the second step, ED95 of both agents calculated in the first step were administered, endpoints of efficacy, safety, and incidence of adverse events were compared. A total of 46 individuals completed the first step. The ED95 of remimazolam was 0.163 mg/kg (95% CI 0.160-0.170 mg/kg), and that of propofol was 1.042 mg/kg (95% CI 1.007-1.112 mg/kg). In the second step, 240 patients completed the trial. The anesthetic effective rates of the remimazolam group and the propofol group were 78% and 83%, respectively, with no statistical difference (P = 0.312). Patients in the remimazolam group had more stable circulatory functions (P < 0.0001) and a lower incidence of pain on injection (3.3% vs. 19.5%, P < 0.0001). The incidence of hypotension was low in the remimazolam versus propofol group (15.6% vs. 39.0%, P < 0.0001). Overall adverse event was low in the remimazolam versus propofol group (21.3% vs. 62.7%, P < 0.0001).In this study, we found that when anesthesia was administered to elderly gastroscopy patients based on 95% effective doses of remimazolam and propofol, remimazolam was as effective as propofol, but was safer with a lower incidence of adverse events.Study registration: Chinese Clinical Trial Registry, ChiCTR2000034234. Registered 29/06/2020, https://www.chictr.org.cn .
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Affiliation(s)
- Di Chen
- The Second Affiliated Hospital of Hainan Medical University, Haikou, China
| | - Min Liao
- The Second Affiliated Hospital of Hainan Medical University, Haikou, China
| | - Xiao-Ru Wu
- The Second Affiliated Hospital of Hainan Medical University, Haikou, China
| | | | - Hu Sun
- The Second Affiliated Hospital of Hainan Medical University, Haikou, China.
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Chen Q, Qin B, Zhang M, Zhou Y, Shi X, Xie Y. The Safety and Efficacy of Remimazolam Compared to Dexmedetomidine for Awake Tracheal Intubation by Flexible Bronchoscopy: A Randomized, Double-Blind, Controlled Trial. Drug Des Devel Ther 2024; 18:967-978. [PMID: 38562518 PMCID: PMC10984194 DOI: 10.2147/dddt.s446222] [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: 10/24/2023] [Accepted: 03/14/2024] [Indexed: 04/04/2024] Open
Abstract
Background Remimazolam is a novel ultra-short-acting benzodiazepine sedative that has the potential to be an alternative for procedural sedation due to its rapid sedation and recovery, no accumulation effect, stable hemodynamics, minimal respiratory depression, anterograde amnesia effect, and specific antagonist. Here, we aimed to compare the safety and efficacy of remimazolam with dexmedetomidine for awake tracheal intubation by flexible bronchoscopy (ATI-FB). Methods Ninety patients scheduled for ATI-FB were randomly divided into three groups, each consisting of 30 cases: dexmedetomidine 0.6 µg/kg + sufentanil (group DS), remimazolam 0.073 mg/kg + sufentanil (group R1S), or remimazolam 0.093 mg/kg + sufentanil (group R2S). The primary outcome was the success rate of sedation. Secondary outcomes were MOAA/S scores, hemodynamic and respiratory parameters, intubation conditions, intubation time, tracheal intubation amnesia, and adverse events. Results The success rates of sedation in groups R2S and DS were higher than that in group R1S (93.3%, 86.7%, respectively, vs 58.6%; P = 0.002), and intubation conditions were better than those in group R1S (P < 0.05). Group R2S had shorter intubation times than groups R1S and DS (P = 0.003), and a higher incidence of tracheal intubation amnesia than group DS (P = 0.006). No patient in the three groups developed hypoxemia or hypotension, and there were no significant differences in oligopnea, PetCO2, or bradycardia (P > 0.05). Conclusion In conclusion, both DS and R2S had higher success rates of sedation, better intubation conditions, and minor respiratory depression, but R2S, with its shorter intubation time, higher incidence of anterograde amnesia, and ability to be antagonized by specific antagonists, may be a good alternative sedation regimen for patients undergoing ATI-FB.
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Affiliation(s)
- Qiumiao Chen
- Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, People’s Republic of China
| | - Bin Qin
- Department of Anesthesiology, College of Stomatology, Hospital of Stomatology, Guangxi Medical University, Nanning, People’s Republic of China
| | - Manqing Zhang
- Department of Anesthesiology, College of Stomatology, Hospital of Stomatology, Guangxi Medical University, Nanning, People’s Republic of China
| | - Yumei Zhou
- Department of Anesthesiology, College of Stomatology, Hospital of Stomatology, Guangxi Medical University, Nanning, People’s Republic of China
| | - Xiaotong Shi
- Department of Anesthesiology, College of Stomatology, Hospital of Stomatology, Guangxi Medical University, Nanning, People’s Republic of China
| | - Yubo Xie
- Department of Anesthesiology, The First Affiliated Hospital of Guangxi Medical University, Nanning, People’s Republic of China
- Guangxi Key Laboratory of Enhanced Recovery After Surgery for Gastrointestinal Cancer, The First Affiliated Hospital of Guangxi Medical University, Nanning, People’s Republic of China
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50
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Lan H, Cao H, Liu S, Gong X, Huang X, Rong H, Xu B, Chen H, Jiao Z, Lin Y, Guan X. Efficacy of remimazolam tosilate versus propofol for total intravenous anaesthesia in urological surgery: A randomised clinical trial. Eur J Anaesthesiol 2024; 41:208-216. [PMID: 38165145 DOI: 10.1097/eja.0000000000001938] [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: 01/03/2024]
Abstract
BACKGROUND Remimazolam is a novel ultra-short-acting benzodiazepine sedative that acts on the gamma-aminobutyric acid type A receptor (GABAAR). OBJECTIVE To compare the efficacies of remimazolam (RMZ), and propofol (PROP) combined with remifentanil and cisatracurium for total intravenous anaesthesia (TIVA) in patients undergoing urological surgery. DESIGN A prospective, single-blind, randomised, noninferiority clinical trial. SETTING Single centre from 1 January 2022 to 30 March 2022. PATIENTS A total of 146 adult patients undergoing elective urological surgery. INTERVENTION Patients were randomly allocated in a 1 : 1 ratio to the PROP or RMZ groups. In the PROP group, anaesthesia was induced with propofol at 100 mg min -1 to reach a bispectral index score (BIS) of 40 to 60. After loss of consciousness (LOC), intravenous fentanyl 3 μg kg -1 was administered, followed by cisatracurium 0.3 mg kg -1 . Patients were intubated 3 min after cisatracurium administration. Anaesthesia was maintained with the combination of propofol (plasma concentration: 2.5 to 4 μg ml -1 ) and remifentanil (plasma concentration: 2.5 to 4 ng ml -1 ). In the RMZ group, anaesthesia was induced with remimazolam tosilate starting at 10 mg kg -1 h -1 to reach a BIS of 40 to 60 and maintained between 0.2 and 2 mg kg -1 h -1 . After LOC, fentanyl and cisatracurium were administered and intubation was performed as in the PROP group. Anaesthesia was maintained with a combination of remimazolam (0.2 to 2 mg kg -1 h -1 ) and remifentanil (plasma concentration: 2.5 to 4 ng ml -1 ). MAIN OUTCOME MEASURES The primary outcome was the TIVA success rate. The predefined noninferiority margin considered an absolute difference of 6% in the primary outcome between the groups. The secondary outcomes were vital signs, anaesthesia and surgery characteristics, and adverse events. RESULTS All patients completed the trial. The success rates of TIVA with remimazolam and propofol were 100 and 98.6%, respectively. The incidence of hypotension during anaesthesia was lower in the RMZ group (26%) than in the PROP group (46.6%) ( P = 0.016). The median [IQR] total consumption of ephedrine during anaesthesia was higher in the PROP group 10 [0 to 12.5] mg than in the RMZ group 0 [0 to 10] mg ( P = 0.0002). The incidence of injection pain was significantly higher in the PROP group (76.7%) than in the RMZ group (0; P < 0.001). No significant differences in the controllability of the anaesthesia depth, anaesthesia and surgery characteristics, or vital signs were observed between the groups. CONCLUSION Remimazolam demonstrated noninferior efficacy to propofol combined with remifentanil and cisatracurium for TIVA in patients undergoing urological surgery. TRIAL REGISTRATION Chictr.org.cn, identifier: ChiCTR2100050923. CLINICAL REGISTRATION The study was registered in the Chinese Clinical Trial Registry (ChiCTR2100050923, Principal investigator: Xuehai Guan, Date of registration: 8 November 2021, https://www.chictr.org.cn/showproj.html?proj=133466 ).
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Affiliation(s)
- Hongmeng Lan
- From the Department of Anaesthesiology, The First Affiliated Hospital of Guangxi Medical University (HL, HC, SL, XG, XH, HR, ZJ, YL, XG), Department of Rehabilitation, People's Hospital of Guangxi Zhuang Autonomous Region (BX) and Department of Rehabilitation, The First Affiliated Hospital of Guangxi Medical University (HC)
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