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Kimura S, Sone M, Sugawara S, Itou C, Ozawa M, Sato T, Matsui Y, Arai Y, Kusumoto M. Safety of propofol sedation administered by interventional radiologists for radiofrequency ablation in patients with hepatocellular carcinoma. Jpn J Radiol 2024; 42:1290-1297. [PMID: 38922567 PMCID: PMC11522072 DOI: 10.1007/s11604-024-01615-2] [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: 02/14/2024] [Accepted: 06/16/2024] [Indexed: 06/27/2024]
Abstract
PURPOSE To evaluate the safety of propofol sedation administered by interventional radiologists during radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). MATERIALS AND METHODS Propofol sedation was administered by interventional radiologists in 72 patients (85 procedures, 93 tumors) during RFA for HCC between August 2018 and December 2020. Interventional radiologists equipped with adequate knowledge and skills in sedation and respiratory management were responsible for sedation. Sedation was carefully assessed based on vital signs, including end-tidal carbon dioxide, consciousness status, and bispectral index. The primary endpoint was the incidence of sedation-related complications, which were evaluated separately as respiratory and cardiovascular complications. Secondary endpoints were technical success rate, ablation-related complications, and local tumor control rate. Technical success was defined as completion of ablation in the planned area. Complications were evaluated using the Clavien-Dindo classification. Sedation-related complications, technical success rate, and ablation-related complications were evaluated on a procedure basis, and local tumor control was evaluated on a tumor basis. RESULTS Respiratory and cardiovascular complications were observed in eight (8/85, 9.4%) and two (2/85, 2.4%) patients, respectively. Four patients required the jaw thrust maneuver due to glossoptosis, whereas a decrease in oxygen saturation to < 90% was recorded in the other four patients. However, these were temporary, and none required manual ventilation or endotracheal intubation. Bradycardia (< 50 bpm) was detected in two patients; one recovered immediately without treatment, whereas the other rapidly improved after atropine sulfate administration. No severe hypotension (< 80 mmHg) was observed. The technical success rate was 100% (85/85). Grade 3 ablation-related complications were identified in three patients (3/85, 3.5%). The local tumor control rate was 95.7% (89/93). CONCLUSION Propofol sedation can be safely administered by interventional radiologists during RFA for HCC. Although it requires special safety considerations, it may be a sedation option during hepatic RFA.
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Affiliation(s)
- Shintaro Kimura
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
- Cancer Medicine, The Jikei University Graduate School of Medicine, Tokyo, Japan.
| | - Miyuki Sone
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
| | - Shunsuke Sugawara
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
| | - Chihiro Itou
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
| | - Mizuki Ozawa
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
- Cancer Medicine, The Jikei University Graduate School of Medicine, Tokyo, Japan
| | - Tetsufumi Sato
- Department of Anesthesia and Intensive Care, National Cancer Center Hospital, Tokyo, Japan
| | - Yoshiyuki Matsui
- Cancer Medicine, The Jikei University Graduate School of Medicine, Tokyo, Japan
- Department of Urology, National Cancer Center Hospital, Tokyo, Japan
| | - Yasuaki Arai
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
| | - Masahiko Kusumoto
- Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
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González-Mendibil I, García-Pascual E, Villanueva A, García-Gutiérrez S. Bispectral index monitoring for sedation in scheduled adult colonoscopy: A randomized controlled trial. REVISTA ESPANOLA DE ANESTESIOLOGIA Y REANIMACION 2024; 71:633-644. [PMID: 38663652 DOI: 10.1016/j.redare.2024.04.011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/14/2023] [Revised: 11/02/2023] [Accepted: 12/06/2023] [Indexed: 05/01/2024]
Abstract
BACKGROUND Patients should be closely monitored during procedures under sedation outside the operating room, but it is unclear which type of monitoring is best. We investigated the efficacy and safety of BIS monitoring vs conventional monitoring for sedation during colonoscopy. METHODS We performed a double-blind clinical trial in 180 patients undergoing elective colonoscopy. Patients were randomized to 1) the BIS group or 2) a control group, in which sedation was monitored with a BIS monitor or the Ramsay Sedation Score, respectively. The primary outcome was the rate of sedation-induced adverse events in both groups. Secondary outcomes were the characteristics of patients who developed adverse events, and time during colonoscopy when these events occurred, propofol and remifentanil dosage, and patient satisfaction. RESULTS Univariate analysis showed fewer cardiopulmonary complications in the BIS group (41.11% vs 57.78% in controls; p = 0.02). Multivariate analysis found a significantly higher risk of adverse events in older patients (95% CI, 1.013-1.091; p = 0.0087) and in men (95% CI, 1.129-7.668; p = 0.0272). These events were observed at the hepatic flexure. No significant differences between propofol or remifentanil dosage, use of rescue medication, and patient satisfaction were observed between groups. CONCLUSIONS Our data suggest that BIS monitoring during sedation in scheduled colonoscopies reduces adverse respiratory events. Although its routine use in sedation does not appear to be warranted, clinicians should take steps to identify patients with a higher risk of complications who might benefit from this type of monitoring.
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Affiliation(s)
- I González-Mendibil
- Department of Anesthesiology, Galdakao University Hospital, Galdakao, Bizkaia, Spain.
| | - E García-Pascual
- Department of Anesthesiology, Galdakao University Hospital, Galdakao, Bizkaia, Spain
| | - A Villanueva
- Research Unit, Galdakao University Hospital, Galdakao, Bizkaia, Spain; Kronikgune Institute for Health Services Research, Barakaldo, Bizkaia, Spain
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Soliman AM, Hamad YM, Almaghraby AA, Mohamed AA, Abdallah SR. Propofol versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: Randomized Single-Blinded Controlled Study. Anesth Pain Med 2024; 14:e148512. [PMID: 40078472 PMCID: PMC11895786 DOI: 10.5812/aapm-148512] [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: 05/13/2024] [Revised: 07/12/2024] [Accepted: 07/27/2024] [Indexed: 03/14/2025] Open
Abstract
Background Endoscopic retrograde cholangiopancreatography (ERCP) is a primary diagnostic and therapeutic option for pancreaticobiliary pathologies. Objectives This study aimed to investigate the efficacy and safety of dexmedetomidine versus propofol during ERCP in cancer patients. Methods This randomized controlled single-blinded trial was conducted with 202 cancer patients aged 21 to 60 years, of both sexes, with a body mass index of 18.5 to 30 kg/m2, and classified as American Society of Anesthesiologists (ASA) class II - III, who were undergoing ERCP. The patients were randomly assigned to two equal groups. The Propofol Group (n = 101) received a loading dose of propofol (1 - 2 mg/kg over 30 seconds) followed by an infusion (0.05 - 0.1 mg/kg/hour). The Dexmedetomidine Group (n = 101) received a loading dose of dexmedetomidine (1 μg/kg over 10 minutes) followed by an infusion (0.2 - 0.7 μg/kg/hour). The maintenance dose was adjusted during the procedure based on vital signs, Bispectral Index (BIS), and oxygen saturation. Results The Dexmedetomidine group showed a significantly lower incidence of intra-procedural hypoxemic events (14.9% vs. 26.7%, P = 0.037) and a comparable incidence of hypotension (17.8% vs. 13.9%, P = 0.441). Dexmedetomidine also demonstrated significantly lower intraoperative pain scores according to the Facial Pain Score (P < 0.05), significantly lower postoperative Visual Analog Scale (VAS) scores (P < 0.05), and a lower frequency of postoperative nausea and vomiting (PONV) compared to the Propofol group. Additionally, there was a significantly higher frequency of endoscopist satisfaction in the Dexmedetomidine group compared to the Propofol group (P < 0.05). Conclusions Dexmedetomidine can be used as a safe and effective alternative to propofol for deep sedation of cancer patients undergoing ERCP. It is associated with a lower incidence of hypoxemic events, effective intraoperative sedation, quicker recovery, and superior analgesic effects both intraoperatively and postoperatively compared to propofol.
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Affiliation(s)
- Ahmed Mohamed Soliman
- Anaesthesia, ICU and Pain Management Department, National Cancer Institute, Cairo University, Giza, Egypt
| | - Yehya Mohamed Hamad
- Anaesthesia, ICU and Pain Management Department, Faculty of Medicine, Cairo University, Giza, Egypt
| | | | - Ahmed Abdalla Mohamed
- Anaesthesia, ICU and Pain Management Department, Faculty of Medicine, Cairo University, Giza, Egypt
| | - Shady Rady Abdallah
- Anaesthesia, ICU and Pain Management Department, Faculty of Medicine, Cairo University, Giza, Egypt
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Zhang Y, Zhang N, Hu J, Liu C, Li G. Safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation of elderly patients undergoing ERCP. BMC Gastroenterol 2024; 24:124. [PMID: 38566038 PMCID: PMC10985874 DOI: 10.1186/s12876-024-03197-9] [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: 11/01/2023] [Accepted: 03/06/2024] [Indexed: 04/04/2024] Open
Abstract
BACKGROUND Proper sedation of patients, particularly elderly individuals, who are more susceptible to sedation-related complications, is of significant importance in endoscopic retrograde cholangiopancreatography (ERCP). This study aims to assess the safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation in elderly patients undergoing ERCP, compared to a group of middle-aged patients. METHODS The medical records of 610 patients with common bile duct stones who underwent elective ERCP under deep sedation with a three-drug regimen, including midazolam, alfentanil, and propofol at Shandong Provincial Third Hospital from January 2023 to September 2023 were retrospectively reviewed in this study. Patients were categorized into three groups: middle-aged (50-64 years, n = 202), elderly (65-79 years, n = 216), and very elderly (≥ 80 years, n = 192). Intraoperative vital signs and complications were compared among these groups. RESULTS The three groups showed no significant difference in terms of intraoperative variation of systolic blood pressure (P = 0.291), diastolic blood pressure (P = 0.737), heart rate (P = 0.107), peripheral oxygen saturation (P = 0.188), bispectral index (P = 0.158), and the occurrence of sedation-related adverse events including hypotension (P = 0.170) and hypoxemia (P = 0.423). CONCLUSION The results suggest that a low-dose three-drug regimen consisting of midazolam, alfentanil, and propofol seems safe and effective for deep sedation of elderly and very elderly patients undergoing ERCP procedures. However, further studies are required to verify these findings and clarify the benefits and risks of this method.
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Affiliation(s)
- Yanping Zhang
- Department of Anesthesiology, Cheeloo College of Medicine, Shandong Provincial Third Hospital, Shandong University, No.12 Wuyingshan Middle Road, Jinan, Shandong, 250000, China
| | - Ning Zhang
- Department of Cardiopulmonary rehabilitation, Cheeloo College of Medicine, Shandong Provincial Third Hospital, Shandong University, No.12 Wuyingshan Middle Road, Jinan, Shandong, 250000, China
| | - Jing Hu
- Department of Anesthesiology, Cheeloo College of Medicine, Shandong Provincial Third Hospital, Shandong University, No.12 Wuyingshan Middle Road, Jinan, Shandong, 250000, China
| | - Changlin Liu
- Department of Anesthesiology, Cheeloo College of Medicine, Shandong Provincial Third Hospital, Shandong University, No.12 Wuyingshan Middle Road, Jinan, Shandong, 250000, China
| | - Guanjun Li
- Department of Anesthesiology, Cheeloo College of Medicine, Shandong Provincial Third Hospital, Shandong University, No.12 Wuyingshan Middle Road, Jinan, Shandong, 250000, China.
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Su D, Zhang W, Li J, Tan X, Wei H, Wang Y, Ji Z. Supraglottic jet oxygenation and ventilation improves oxygenation during endoscopic retrograde cholangiopancreatography: a randomized controlled clinical trial. BMC Anesthesiol 2024; 24:21. [PMID: 38216874 PMCID: PMC10785419 DOI: 10.1186/s12871-024-02406-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/26/2023] [Accepted: 01/07/2024] [Indexed: 01/14/2024] Open
Abstract
PURPOSE Hypoxia is one of the most frequent adverse events under deep sedation in the semiprone position. We hypothesized that supraglottic jet oxygenation and ventilation (SJOV) via Wei nasal jet tube (WNJ) can reduce the incidence of hypoxia in patients under deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). METHODS A total of 171 patients were divided into three groups: N group, supplementary oxygen via a nasopharyngeal airway (4-6 L/min); W group, supplementary oxygen via WNJ (4-6 L/min); WS group, SJOV via WNJ. The primary outcome was the incidence of adverse events, including sedation-related adverse events [SRAEs, hypoxemia (SpO2 = 75-89% lasted less than 60 s); severe hypoxemia (SpO2 < 75% at any time or SpO2 < 90% lasted more than 60 s] and subclinical respiratory depression (SpO2 = 90-95%). Other intraoperative and post-operative adverse events were also recorded as secondary outcomes. RESULTS Compared with the N group, the incidence of hypoxemia and subclinical respiratory depression in the WS group was significantly lower (21% vs. 4%, P = 0.005; 27% vs. 6%, P = 0.002). Compared with Group W, the incidence of hypoxemia and subclinical respiratory depression in Group WS was also significantly less frequent (20% vs. 4%, P = 0.009; 21% vs. 6%, P = 0.014). No severe hypoxia occurred in the group WS, while four and one instances were observed in the group N and group W respectively. There were no significant differences in other adverse events among the three groups. CONCLUSION SJOV can effectively improve oxygenation during ERCP in deeply sedated semiprone patients.
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Affiliation(s)
- Dan Su
- Department of Anesthesia, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China
| | - Wei Zhang
- Department of Anesthesia, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China
| | - Jingze Li
- Endoscopy Center, Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China
| | - Xi Tan
- Endoscopy Center, Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China
| | - Huafeng Wei
- Department of Anesthesiology and Critical Care Medicine, University of Pennsylvania, Philadelphia, PA, 19104, USA
| | - Yinglin Wang
- Department of Anesthesia, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China.
| | - Zhonghua Ji
- Department of Anesthesia, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China.
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Wehrmann T, Riphaus A, Eckardt AJ, Klare P, Kopp I, von Delius S, Rosien U, Tonner PH. Updated S3 Guideline "Sedation for Gastrointestinal Endoscopy" of the German Society of Gastroenterology, Digestive and Metabolic Diseases (DGVS) - June 2023 - AWMF-Register-No. 021/014. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:e654-e705. [PMID: 37813354 DOI: 10.1055/a-2165-6388] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/11/2023]
Affiliation(s)
- Till Wehrmann
- Clinic for Gastroenterology, DKD Helios Clinic Wiesbaden, Wiesbaden, Germany
| | - Andrea Riphaus
- Internal Medicine, St. Elisabethen Hospital Frankfurt Artemed SE, Frankfurt, Germany
| | - Alexander J Eckardt
- Clinic for Gastroenterology, DKD Helios Clinic Wiesbaden, Wiesbaden, Germany
| | - Peter Klare
- Department Internal Medicine - Gastroenterology, Diabetology, and Hematology/Oncology, Hospital Agatharied, Hausham, Germany
| | - Ina Kopp
- Association of the Scientific Medical Societies in Germany e.V. (AWMF), Berlin, Germany
| | - Stefan von Delius
- Medical Clinic II - Internal Medicine - Gastroenterology, Hepatology, Endocrinology, Hematology, and Oncology, RoMed Clinic Rosenheim, Rosenheim, Germany
| | - Ulrich Rosien
- Medical Clinic, Israelite Hospital, Hamburg, Germany
| | - Peter H Tonner
- Anesthesia and Intensive Care, Clinic Leer, Leer, Germany
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Wehrmann T, Riphaus A, Eckardt AJ, Klare P, Kopp I, von Delius S, Rosien U, Tonner PH. Aktualisierte S3-Leitlinie „Sedierung in der gastrointestinalen Endoskopie“ der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS). ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:1246-1301. [PMID: 37678315 DOI: 10.1055/a-2124-5333] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/09/2023]
Affiliation(s)
- Till Wehrmann
- Klinik für Gastroenterologie, DKD Helios Klinik Wiesbaden, Wiesbaden, Deutschland
| | - Andrea Riphaus
- Innere Medizin, St. Elisabethen Krankenhaus Frankfurt Artemed SE, Frankfurt, Deutschland
| | - Alexander J Eckardt
- Klinik für Gastroenterologie, DKD Helios Klinik Wiesbaden, Wiesbaden, Deutschland
| | - Peter Klare
- Abteilung Innere Medizin - Gastroenterologie, Diabetologie und Hämato-/Onkologie, Krankenhaus Agatharied, Hausham, Deutschland
| | - Ina Kopp
- Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF), Berlin, Deutschland
| | - Stefan von Delius
- Medizinische Klinik II - Innere Medizin - Gastroenterologie, Hepatologie, Endokrinologie, Hämatologie und Onkologie, RoMed Klinikum Rosenheim, Rosenheim, Deutschland
| | - Ulrich Rosien
- Medizinische Klinik, Israelitisches Krankenhaus, Hamburg, Deutschland
| | - Peter H Tonner
- Anästhesie- und Intensivmedizin, Klinikum Leer, Leer, Deutschland
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Effect of the using a pupillometer on recovery and early cognitive functions in anesthesia management for endoscopic retrograde cholangiopancreaticography in geriatric patients. JOURNAL OF SURGERY AND MEDICINE 2023. [DOI: 10.28982/josam.7501] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/19/2023] Open
Abstract
Background/Aim: Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive procedure used for the diagnosis and treatment of pancreaticobiliary pathologies. Because it is an invasive procedure that is difficult to tolerate by the patient and takes a long time, it is preferable to use it under deep patient sedation and even under general anesthesia in some cases. This study aimed to evaluate the effects of using a pupillometer versus the Ramsey sedation scale (RSS) during anesthesia management for ERCP on recovery and return of cognitive functions in the geriatric patient population.
Methods: A mini-mental test was applied to evaluate the pre-operative cognitive functions of the cases before the intervention. The included patients were divided into groups using the sealed-envelope method. Management of the depth of anesthesia was evaluated by Ramsey sedation scale; in group R and was evaluated by pupillometer in group P. The infusion dose of dexmedetomidine was changed to 0.1 µg/kg/h according to the results of the evaluation.
Results: Sixty cases were included in the study. No difference between the groups in terms of age (P=0.246), gender (P=0.797), American Society of Anesthesiologists (ASA) score (P=0.197), comorbidity (P=0.748), anesthesia duration (P=0.397), midazolam doses (P=0.561), propofol doses (P=0.677), and intra-operative hemodynamic values (P=0.668) were found. Intra-operative dexmedetomidine dose was statistically significantly lower (P=0.004), and recovery was faster in group P (P<0.001). While no differences between the groups in the pre-operative mini-mental test scores (P=0.140) were found, the post-operative scores were statistically significantly lower in group R (P=0.025).
Conclusion: In this study, it was observed that the pupillometer led to a reduction in the use of dexmedetomidine and cognitive functions were better during the post-operative recovery period. As a result, depth of anesthesia can be monitored with a pupillometer. Although the use of pupillometer in endoscopic interventions in the geriatric patient group does not make a hemodynamic difference when compared with the RSS, the pupillometer leads to accelerated recovery from anesthesia, improvement in the return of cognitive functions, and reduction in drug consumption.
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Hayashi Y, Hosoe N, Takabayashi K, Limpias Kamiya KJL, Tojo A, Sakurai H, Kinoshita S, Sujino T, Nakayama A, Kato M, Yahagi N, Ogata H, Kanai T. Efficacy of capnographic and bispectral index monitoring on trans-oral therapeutic endoscopy: A prospective observational study. J Gastroenterol Hepatol 2022; 37:2004-2010. [PMID: 35772179 DOI: 10.1111/jgh.15932] [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: 02/21/2022] [Revised: 05/06/2022] [Accepted: 06/18/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND AND AIM Oral therapeutic and invasive endoscopy requires deep sedation to reduce patient distress due to prolonged examination and procedures. The usefulness of capnography and bispectral index (BIS) monitoring in the early hypoxia detection in oral therapeutic and invasive endoscopy has yet to be evaluated. This study aimed to investigate the clinical impact of capnography and BIS monitoring on hypoxic events during oral therapeutic and invasive endoscopic procedures. METHODS This is a prospective observational study. Trans-oral non-intubated therapeutic and/or invasive endoscopic procedures were performed with conventional monitoring (pulse oximetry, pulse, and blood pressure) as well as additional monitoring (BIS and end-tidal CO2 concentration). Hypoxia is defined as oxygen saturation of <90% that lasts >15 s. The clinical impact of capnography and BIS monitoring on hypoxic events during oral therapeutic and invasive endoscopic procedures were investigated with the risk factors for hypoxia in each patient. RESULTS Patients with hypoxia had significantly more apneas detected using capnography than other patients. The multivariate analysis revealed the detected apnea by capnography as an independent risk factor for hypoxia (odds ratio: 3.48[95% confidence interval: 1.24-9.78], P = 0.02). The BIS was not significantly different as a risk factor for hypoxia; however, per-event analysis revealed significantly decreased BIS values over time in 3 min before hypoxic events. CONCLUSIONS Apnea detected by capnography was an independent predictor of hypoxia. The BIS value was not associated with hypoxia events; however, it showed a significant downward trend before hypoxia events.
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Affiliation(s)
- Yukie Hayashi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Naoki Hosoe
- Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan
| | - Kaoru Takabayashi
- Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan
| | - Kenji J L Limpias Kamiya
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Anna Tojo
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Hinako Sakurai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Satoshi Kinoshita
- Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan
| | - Tomohisa Sujino
- Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan
| | - Atsushi Nakayama
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Motohiko Kato
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Naohisa Yahagi
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Haruhiko Ogata
- Center for Diagnostic and Therapeutic Endoscopy, Keio University School of Medicine, Tokyo, Japan
| | - Takanori Kanai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
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Park SW. Clinical and economic value of bispectral index monitoring for adequate endoscopic sedation. Clin Endosc 2022; 55:518-519. [PMID: 35898154 PMCID: PMC9329650 DOI: 10.5946/ce.2022.110] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2022] [Accepted: 03/30/2022] [Indexed: 11/14/2022] Open
Affiliation(s)
- Se Woo Park
- Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea
- Correspondence: Se Woo Park Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong 18450, Korea E-mail:
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Okamoto A, Kamata K, Miyata T, Yoshikawa T, Ishikawa R, Yamazaki T, Nakai A, Omoto S, Minaga K, Yamao K, Takenaka M, Chiba Y, Sakurai T, Nishida N, Kitano M, Kudo M. Bispectral index-guided propofol sedation during endoscopic ultrasonography. Clin Endosc 2022; 55:558-563. [PMID: 35817564 PMCID: PMC9329640 DOI: 10.5946/ce.2022.001] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Accepted: 02/21/2022] [Indexed: 11/22/2022] Open
Abstract
Background/Aims Bispectral index (BIS) monitors process and display electroencephalographic data are used to assess the depth of anesthesia. This study retrospectively evaluated the usefulness of BIS monitoring during endoscopic ultrasonography (EUS).
Methods This study included 725 consecutive patients who underwent EUS under sedation with propofol. BIS monitoring was used in 364 patients and was not used in 361. The following parameters were evaluated: (1) median dose of propofol; (2) respiratory and circulatory depression; (3) occurrence of body movements; (4) awakening score >8 at the time; and (5) awakening score 2 hours after leaving the endoscopy room.
Results The BIS group received a significantly lower median dose of propofol than the non-BIS group (159.2 mg vs. 167.5 mg; p=0.015) in all age groups. For patients aged ≥75 years, the reduction in heart rate was significantly lower in the BIS group than in the non-BIS group (1.2% vs. 9.1%; p=0.023). Moreover, the occurrence of body movements was markedly lower in the BIS group than in the non-BIS group (8.5% vs. 39.4%; p<0.001).
Conclusions During EUS examination, BIS monitoring is useful for maintaining a constant depth of anesthesia, especially in patients 75 years of age or older.
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Affiliation(s)
- Ayana Okamoto
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Ken Kamata
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Takeshi Miyata
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Tomoe Yoshikawa
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Rei Ishikawa
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Tomohiro Yamazaki
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Atsushi Nakai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Shunsuke Omoto
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Kosuke Minaga
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Kentaro Yamao
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Mamoru Takenaka
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Yasutaka Chiba
- Clinical Research Center, Kindai University Hospital, Osakasayama, Japan
| | - Toshiharu Sakurai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Naoshi Nishida
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
| | - Masayuki Kitano
- Second Department of Internal Medicine, Wakayama Medical University School of Medicine, Wakayama, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osakasayama, Japan
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12
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Velegraki M, Manolaraki M, Chainaki I, Vardas E, Petrodaskalaki M, Androulakis N, Georgakaki C, Lazanaki E, Chlouverakis G, Paspatis GA. Cerebral oximetry monitoring in non-intubated patients undergoing endoscopic retrograde cholangiopancreatography under propofol-induced sedation: a prospective observational study. Ann Gastroenterol 2021; 34:736-742. [PMID: 34475746 PMCID: PMC8375660 DOI: 10.20524/aog.2021.0637] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2021] [Accepted: 03/18/2021] [Indexed: 11/30/2022] Open
Abstract
Background Prolonged propofol-induced deep sedation increases the risk for sedation-related complications. Cerebral oximetry enables prompt assessment of tissue oxygenation by demonstrating the regional hemoglobin oxygen saturation (rSO2) of the cerebral cortex. This study aimed to: evaluate cerebral oxygenation under deep sedation during an endoscopic retrograde cholangiopancreatography (ERCP) procedure; determine the cerebral desaturation event (CDE) rate; and assess the predictive capacity of CDEs for sedation-related complications. Methods All consecutive patients who underwent ERCP between September and December 2019 were included prospectively. Propofol monotherapy was used and sedation level was assessed using the bispectral index (BIS). The target level of sedation was deep sedation, defined by BIS values 40-60. Participants were monitored with arterial blood gas analysis and INVOS 5100C cerebral oximeter. RSO2 values were registered prior to sedation (baseline value), every 5 min during the sedation period and at recovery of consciousness. BIS values were recorded simultaneously. CDE was defined as a drop >10% from individual baseline rSO2. Results Sixty patients were enrolled. Mean baseline rSO2 was 65.1% and BIS values ranged from 18-85. No significant correlation was observed between mean rSO2 measurements and mean BIS values throughout the recordings (P = 0.193). Data from patients aged ≥65 years were analyzed separately and the results were similar. The CDE rate was 2.7%, but no CDE was associated with clinical manifestations. Twelve sedation-related complications occurred without the presence of cerebral desaturation. Conclusion Cerebral oxygenation remained independent of changes in sedation depth and cerebral oximetry monitoring did not detect complications earlier than standard monitors.
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Affiliation(s)
- Magdalini Velegraki
- Department of Gastroenterology, Venizeleion General Hospital (Magdalini Velegraki, Emmanouil Vardas, Gregorios A. Paspatis)
| | - Maria Manolaraki
- Department of Anesthesiology, Venizeleion General Hospital (Maria Manolaraki, Irene Chainaki, Nikolaos Androulakis, Chrysanthi Georgakaki, Evangelia Lazanaki)
| | - Irene Chainaki
- Department of Anesthesiology, Venizeleion General Hospital (Maria Manolaraki, Irene Chainaki, Nikolaos Androulakis, Chrysanthi Georgakaki, Evangelia Lazanaki)
| | - Emmanouil Vardas
- Department of Gastroenterology, Venizeleion General Hospital (Magdalini Velegraki, Emmanouil Vardas, Gregorios A. Paspatis)
| | - Maria Petrodaskalaki
- Department of Quality and Research, University Hospital of Heraklion (Maria Petrodaskalaki)
| | - Nikolaos Androulakis
- Department of Anesthesiology, Venizeleion General Hospital (Maria Manolaraki, Irene Chainaki, Nikolaos Androulakis, Chrysanthi Georgakaki, Evangelia Lazanaki)
| | - Chrysanthi Georgakaki
- Department of Anesthesiology, Venizeleion General Hospital (Maria Manolaraki, Irene Chainaki, Nikolaos Androulakis, Chrysanthi Georgakaki, Evangelia Lazanaki)
| | - Evangelia Lazanaki
- Department of Anesthesiology, Venizeleion General Hospital (Maria Manolaraki, Irene Chainaki, Nikolaos Androulakis, Chrysanthi Georgakaki, Evangelia Lazanaki)
| | - Gregorios Chlouverakis
- Department of Social Medicine, Biostatistics Lab, School of Medicine, University of Crete, Voutes University Campus (Gregorios Chlouverakis); Crete, Greece
| | - Gregorios A Paspatis
- Department of Gastroenterology, Venizeleion General Hospital (Magdalini Velegraki, Emmanouil Vardas, Gregorios A. Paspatis)
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Gotoda T, Akamatsu T, Abe S, Shimatani M, Nakai Y, Hatta W, Hosoe N, Miura Y, Miyahara R, Yamaguchi D, Yoshida N, Kawaguchi Y, Fukuda S, Isomoto H, Irisawa A, Iwao Y, Uraoka T, Yokota M, Nakayama T, Fujimoto K, Inoue H. Guidelines for sedation in gastroenterological endoscopy (second edition). Dig Endosc 2021; 33:21-53. [PMID: 33124106 DOI: 10.1111/den.13882] [Citation(s) in RCA: 47] [Impact Index Per Article: 11.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2020] [Revised: 10/12/2020] [Accepted: 10/21/2020] [Indexed: 12/14/2022]
Abstract
Sedation in gastroenterological endoscopy has become an important medical option in routine clinical care. Here, the Japan Gastroenterological Endoscopy Society and the Japanese Society of Anesthesiologists together provide the revised "Guidelines for sedation in gastroenterological endoscopy" as a second edition to address on-site clinical questions and issues raised for safe examination and treatment using sedated endoscopy. Twenty clinical questions were determined and the strength of recommendation and evidence quality (strength) were expressed according to the "MINDS Manual for Guideline Development 2017." We were able to release up-to-date statements related to clinical questions and current issues relevant to sedation in gastroenterological endoscopy (henceforth, "endoscopy"). There are few reports from Japan in this field (e.g., meta-analyses), and many aspects have been based only on a specialist consensus. In the current scenario, benzodiazepine drugs primarily used for sedation during gastroenterological endoscopy are not approved by national health insurance in Japan, and investigations regarding expense-related disadvantages have not been conducted. Furthermore, including the perspective of beneficiaries (i.e., patients and citizens) during the creation of clinical guidelines should be considered. These guidelines are standardized based on up-to-date evidence quality (strength) and supports on-site clinical decision-making by patients and medical staff. Therefore, these guidelines need to be flexible with regard to the wishes, age, complications, and social conditions of the patient, as well as the conditions of the facility and discretion of the physician.
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Affiliation(s)
- Takuji Gotoda
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Takuji Akamatsu
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Seiichiro Abe
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Yousuke Nakai
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Waku Hatta
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Naoki Hosoe
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Yoshimasa Miura
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Ryoji Miyahara
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Naohisa Yoshida
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Shinsaku Fukuda
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Hajime Isomoto
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Atsushi Irisawa
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Yasushi Iwao
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Toshio Uraoka
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Takeo Nakayama
- Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan
| | - Kazuma Fujimoto
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
| | - Haruhiro Inoue
- Japanese Gastroenterological Endoscopy Society, Tokyo, Japan
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Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part II. Pharmacodynamics of Electroencephalogram Effects. Anesthesiology 2020; 132:652-666. [PMID: 31972657 DOI: 10.1097/aln.0000000000003102] [Citation(s) in RCA: 64] [Impact Index Per Article: 12.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/09/2023]
Abstract
BACKGROUND Remimazolam (CNS 7056) is a new ultra-short acting benzodiazepine for IV sedation. This study aimed to investigate the electroencephalogram (EEG) pharmacodynamics of remimazolam infusion. METHODS Twenty healthy male volunteers received remimazolam as continuous IV infusion of 5 mg/min for 5 min, 3 mg/min for the next 15 min, and 1 mg/min for further 15 min. Continuous EEG monitoring was performed by a neurophysiologic system with electrodes placed at F3, F4, C3, C4, O1, O2, Cz, and Fp1 (10/20 system) and using the Narcotrend Index. Sedation was assessed clinically by using the Modified Observer's Assessment of Alertness and Sedation scale. Pharmacodynamic models were developed for selected EEG variables and Narcotrend Index. RESULTS EEG changes during remimazolam infusion were characterized by an initial increase in beta frequency band and a late increase in delta frequency band. The EEG beta ratio showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.79, and could be modeled successfully using a standard sigmoid Emax model. Narcotrend Index showed a prediction probability of Modified Observer's Assessment of Alertness and Sedation score of 0.74. The time course of Narcotrend Index was described by an extended sigmoid Emax model with two sigmoid terms and different plasma-effect equilibration times. CONCLUSIONS Beta ratio was identified as a suitable EEG variable for monitoring remimazolam sedation. Narcotrend Index appeared less suitable than the beta ratio for monitoring the sedative effect if remimazolam is administered alone.
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Inal FY, Daskaya H, Yilmaz Y, Kocoglu H. Evaluation of bispectral index monitoring efficacy in endoscopic patients who underwent retrograde cholangiopancreatography and received sedoanalgesia. Wideochir Inne Tech Maloinwazyjne 2020; 15:358-365. [PMID: 32489498 PMCID: PMC7233161 DOI: 10.5114/wiitm.2020.93461] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/08/2020] [Accepted: 02/15/2020] [Indexed: 11/29/2022] Open
Abstract
INTRODUCTION Bispectral index (BIS) monitoring provides an objective, non-invasive measurement of the level of consciousness in a sedated patient. AIM In this prospective study, we aimed to investigate the hypothesis that risk of respiratory depression could be reduced and the desired level of sedation with minimal doses of propofol could be achieved by using BIS monitoring in endoscopic retrograde cholangiopancreatography (ERCP) procedures. MATERIAL AND METHODS Sixty patients in the ASA 1-2 category, who were scheduled for an ERCP with sedation, were randomly divided into two groups. The procedure was performed, and sedation was administered so that the patient's Ramsay Sedation Score (RSS) would be 4-5 in the first group (group 1) and the patient's BIS value would be 65-75 in the second group (group 2). Cardiopulmonary complications, the total duration of the procedure, and the total amount of propofol administered were recorded. RESULTS The mean SpO2 measurements at the third minute, fifth minute, and 10th minute were higher in the BIS group (p < 0.001) (p < 0.05). The mean number of respirations during the third, fifth, 10th, and 15th minute of sedation was significantly higher in the RSS group than in the BIS group (p < 0.05). There was no difference between the groups in terms of recovery time, total propofol amount, and additional doses of bolus propofol. CONCLUSIONS BIS monitoring during sedation with propofol for ERCP did not reduce total propofol use, but it may be an efficient guide for the timing of additional dose administration, which could reduce the risk of respiratory depression, and it could be used safely as an objective method in the follow-up of level of sedation.
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Affiliation(s)
- Ferda Yilmaz Inal
- Department of Anaesthesiology and Reanimation, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey
| | - Hayrettin Daskaya
- Department of Anaesthesiology and Reanimation, Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey
| | - Yadigar Yilmaz
- Clinic of Anaesthesiology and Reanimation, Sultan Abdülhamid Han Training and Research Hospital, Istanbul, Turkey
| | - Hasan Kocoglu
- Department of Anaesthesiology and Reanimation, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey
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Song JW, Soh S, Shim JK. Monitored Anesthesia Care for Cardiovascular Interventions. Korean Circ J 2019; 50:1-11. [PMID: 31642214 PMCID: PMC6923237 DOI: 10.4070/kcj.2019.0269] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2019] [Accepted: 08/26/2019] [Indexed: 01/28/2023] Open
Abstract
The interventional cardiology is growing and evolving. Many complex procedures are now performed outside the operating room to manage cardiovascular pathologies which had been traditionally treated with cardiac surgery. Appropriate sedation strategy is crucial for improved patient comfort and successful procedure while ensuring safety. Sedation for cardiovascular intervention is frequently challenging, especially in critically-ill, high-risk patients. This review addresses pre-procedure evaluation and preparation of patients, proper monitoring, commonly used sedatives and analgesics, and considerations for specific procedures. Appropriate depth of sedation and analgesia should be balanced with patient, procedural and institutional factors. Understanding of the pharmacology of sedatives/analgesics, vigilant monitoring, ability and proper preparation for management of potential complications may improve outcomes in patients undergoing sedation for cardiovascular procedures.
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Affiliation(s)
- Jong Wook Song
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Sarah Soh
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Jae Kwang Shim
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
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17
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Jun MR, Yoo JH, Park SY, Na S, Kwon H, Nho JH, Kim SI. Assessment of phase-lag entropy, a new measure of electroencephalographic signals, for propofol-induced sedation. Korean J Anesthesiol 2019; 72:351-356. [PMID: 31366188 PMCID: PMC6676028 DOI: 10.4097/kja.d.19.00019] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2019] [Accepted: 04/16/2019] [Indexed: 12/30/2022] Open
Abstract
Background Phase-lag entropy (PLE) was recently described as a measurement of temporal pattern diversity in the phase relationship between two electroencephalographic signals from prefrontal and frontal montages. This study was performed to evaluate the performance of PLE for assessing the depth of sedation. Methods Thirty adult patients undergoing upper limb surgery with a brachial plexus block were administered propofol by target-controlled infusion. The depth of sedation was assessed using the Observer’s Assessment of Alertness/Sedation (OAA/S) scale. The effect-site concentration (Ce) of propofol was initially started at 0.5 μg/ml and was increased in increments of 0.2 μg/ml until an OAA/S score of 1 was reached. Three minutes after the target Ce was reached, the PLE, bispectral index (BIS), and level of sedation were assessed. Correlations between the OAA/S score and PLE or BIS were determined. The prediction probabilities (Pk) of PLE and BIS were also analyzed. Results The PLE values were closely correlated with the OAA/S scores (Spearman’s Rho = 0.755; P < 0.001) to an extent comparable with the correlation between the BIS and OAA/S score (Spearman’s Rho = 0.788; P < 0.001). The Pk values of PLE and BIS were 0.731 and 0.718, respectively. Conclusions PLE is a new and reliable consciousness monitoring system for assessing the depth of sedation induced by propofol, which is comparable with the BIS.
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Affiliation(s)
- Mi Roung Jun
- Department of Anesthesiology and Pain Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea
| | - Jae Hwa Yoo
- Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Sun Young Park
- Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Sojin Na
- Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Hyerim Kwon
- Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Jae-Hwi Nho
- Department of Orthopedic Surgery, Soonchunhyang University Seoul Hospital, Seoul, Korea
| | - Soon Im Kim
- Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
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18
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Jo YY, Kwak HJ. Sedation Strategies for Procedures Outside the Operating Room. Yonsei Med J 2019; 60:491-499. [PMID: 31124331 PMCID: PMC6536395 DOI: 10.3349/ymj.2019.60.6.491] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/25/2019] [Revised: 04/03/2019] [Accepted: 04/09/2019] [Indexed: 02/07/2023] Open
Abstract
With the rapid development of diagnostic and therapeutic procedures performed outside the operating room (OR), the need for appropriate sedation care has emerged in importance to ensure the safety and comfort of patients and clinicians. The preparation and administration of sedatives and sedation care outside the OR require careful attention, proper monitoring systems, and clinically useful sedation guidelines. This literature review addresses proper monitoring and selection of sedatives for diagnostic and interventional procedures outside the OR. As the depth of sedation increases, respiratory depression and cardiovascular suppression become serious, necessitating careful surveillance using appropriate monitoring equipment.
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Affiliation(s)
- Youn Yi Jo
- Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
| | - Hyun Jeong Kwak
- Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
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Zhang H, Lu Y, Wang L, Lv J, Ma Y, Wang W, Li G, Li Y. Bispectral index monitoring of sedation depth during endoscopy: a meta-analysis with trial sequential analysis of randomized controlled trials. Minerva Anestesiol 2019; 85:412-432. [PMID: 30621373 DOI: 10.23736/s0375-9393.18.13227-5] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
Abstract
INTRODUCTION The Bispectral Index (BIS) provides an objective measure of the level of sedation and general anesthesia. We performed this meta-analysis and trial sequential analysis (TSA) of randomized clinical trials to clarify whether BIS monitoring is helpful in enhancing intraprocedual safety, shortening procedure duration or promoting recovery during sedation for endoscopic procedures. EVIDENCE ACQUISITION PubMed, EMBASE, CINAHL, the Cochrane Central Register of Controlled Trials [CENTRAL]) databases, reference lists of articles as well as relevant articles from "Google Scholar" were searched until May 31st, 2018. Randomized controlled trials (RCTs) comparing BIS with clinical signs for titration of sedation depth during endoscopy were screened and identified if they reported one of the following outcome measures: intraprocedual safety (hemodynamic stability and cardiorespiratory complications such as hypoxia, hypertension/hypotension, and bradycardia/tachycardia), procedure duration, recovery time and patient/endoscopist's satisfaction. EVIDENCE SYNTHESIS Twelve studies with 13 RCTs recruiting 1372 patients were identified with great inter-trial heterogeneity. Meta-analysis found that BIS monitoring of sedation depth was associated with lower incidences of intraprocedural hypoxia (P=0.009) compared with clinical signs which was not confirmed by TSA. Meta-analysis and TSA found that the endoscopic procedure duration (P=0.143), recovery time (P=0.083), satisfaction scores from both the cases (P=0.085) and endoscopists (P=0.125) and the incidences of hypertension/ hypotension (P=0.639) or heart rates (P=0.201) were similar between BIS and control group. CONCLUSIONS More high-quality large-sampled RCTs are needed to confirm whether BIS monitoring for endoscopy sedation helps reduce intraprocedural hypoxia. BIS monitoring fails to shorten procedure duration, promote recovery or boost satisfaction among patients and endoscopists.
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Affiliation(s)
- Hao Zhang
- Department of Anesthesiology, General Hospital of PLA Rocket Force, Beijing, China
| | - Yan Lu
- Department of Neurology, General Hospital of PLA Rocket Force, Beijing, China
| | - Lei Wang
- Department of Neurology, General Hospital of PLA Rocket Force, Beijing, China
| | - Jin Lv
- Department of Nuclear and Radiation Injury, General Hospital of PLA Rocket Force, Beijing, China
| | - Yuheng Ma
- Department of Anesthesiology, General Hospital of PLA Rocket Force, Beijing, China
| | - Wei Wang
- Department of Anesthesiology, General Hospital of PLA Rocket Force, Beijing, China
| | - Guanhua Li
- Department of Anesthesiology, General Hospital of PLA Rocket Force, Beijing, China
| | - Yongwang Li
- Department of Anesthesiology, General Hospital of PLA Rocket Force, Beijing, China -
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20
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Maple JT. Preparation of the Patient for ERCP. ERCP 2019:80-85.e3. [DOI: 10.1016/b978-0-323-48109-0.00010-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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Sargin M, Uluer MS, Şimşek B. The effect of bispectral index monitoring on cognitive performance following sedation for outpatient colonoscopy: a randomized controlled trial. SAO PAULO MED J 2019; 137:305-311. [PMID: 31508796 PMCID: PMC9744010 DOI: 10.1590/1516-3180.2018.0383210519] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2018] [Accepted: 05/21/2019] [Indexed: 12/15/2022] Open
Abstract
BACKGROUND Bispectral index (BIS) monitoring can positively affect cognitive performance through decreasing the use of sedative agents. We aimed to evaluate the effect of BIS monitoring on early cognitive performance among patients undergoing sedation for colonoscopy. DESIGN AND SETTING Randomized, controlled trial in a university hospital. METHODS 100 patients were randomized into two groups. In the monitored group (n = 50), the depth of anesthesia was monitored using the BIS, and BIS scores were maintained between 60 and 80. In the usual care group (n = 50), BIS monitoring was not performed. To determine the patients' baseline cognitive performance levels, the mini-mental state examination (MMSE), Trieger dot test (TDT) and clock drawing test (CDT) were used. The patients' post-procedure cognitive performance levels were determined when they were classified as ready for discharge. RESULTS The total volume (mg) of propofol used [median (range) IQR] in the sedation procedure was lower in the monitored group [100 (50-200) 100-140] than in the usual care group [150 (75-200) 100-200] (P < 0.001). The discharge scores [mean (SD)] using MMSE and CDT were higher in the monitored group [26 (3) and 3 (1), respectively] than in the usual care group [23 (3) and 2 (1), respectively] (P = 0.002 and P = 0.002, respectively). The discharge scores using TDT [mean (SD)] were lower in the monitored group [11 (7)] than in the usual care group [15 (11)] (P = 0.033). CONCLUSION BIS monitoring among sedated patients was associated with lower propofol use and smaller decline in cognitive performance. CLINICAL TRIAL REGISTRATION This trial was registered in the Australian New Zealand Clinical Trial Registry (ACTRN12617000134325).
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Affiliation(s)
- Mehmet Sargin
- MD, Assistant Professor, Anesthesiology and Reanimation Department, Selçuk Üniversitesi Tıp Fakültesi, Konya, Turkey.
| | - Mehmet Selçuk Uluer
- MD. Physician, Anesthesiology and Reanimation Department, Health Sciences University, Konya Eğitim ve Araştırma Hastanesi, Konya, Turkey.
| | - Barış Şimşek
- MD. Physician, Anesthesiology and Reanimation Department, Health Sciences University, Konya Eğitim ve Araştırma Hastanesi, Konya, Turkey.
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Pushkarna G, Sarangal P, Pushkarna V, Gupta R. Comparative Evaluation of Dexmedetomidine versus Midazolam as Premedication to Propofol Anesthesia in Endoscopic Retrograde Cholangiopancreatography. Anesth Essays Res 2019; 13:297-302. [PMID: 31198249 PMCID: PMC6545960 DOI: 10.4103/aer.aer_62_19] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is used to diagnose and treat pancreaticobiliary diseases. It is a potentially uncomfortable procedure that needs to be performed under conscious sedation. Safe and effective sedation protocol is the need of an hour. Aims: This study aims to evaluate the requirement of propofol using midazolam and dexmedetomidine as premedication for ERCP. The degree of comfort experienced by endoscopist and the patients was also assessed. Materials and Methods: A total of sixty patients were enrolled in a randomized, assessor-blinded study in the age group of 40–80 years, American Society of Anesthesiologists physical class II–III undergoing elective ERCP procedures. They were divided into two groups of 30 each. Group D (n = 30): Dexmedetomidine (100 μg/mL + 18 mL saline) loading dose at 1 μg/kg intravenous (IV) over 10 min followed by 0.5 μg/kg/h infusion, and Group M (n = 30): Midazolam at 0.05 mg/kg IV bolus over 10 min followed by normal saline infusion under hemodynamic monitoring. Satisfaction scores, total propofol requirement, and complications such as gagging, restlessness, agitation, postoperative nausea and vomiting were noted and analyzed statistically. Statistical Analysis: Statistical analysis was performed using SSPS 17.0 software (SPSS Inc., 233 South Wacker Drive, Chicago, USA). The Chi-square test was applied for nonparametric data and parametric numerical data, unpaired t-test for intergroup comparison, and repeated measures ANOVA for intragroup comparison. Results were expressed as a mean ± standard deviation. Value of P < 0.05 was considered statistically significant and <0.001 as highly significant. Results: Surgeons and patients were more satisfied and comfortable along with less requirement of propofol in the dexmedetomidine group. The incidence of complications was also less in the dexmedetomidine group as compared to that of midazolam group. Conclusion: Both dexmedetomidine and midazolam can be safely administered as an anesthetic adjuvant to propofol for short procedures like ERCP's. Dexmedetomidine provided intense and better sedation quality along with lesser requirement of propofol doses. Moreover, it provided stable hemodynamic conditions and good recovery characteristics as compared to midazolam group.
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Affiliation(s)
| | - Pankaj Sarangal
- Department of Anaesthesia, SGRDIMSAR, Amritsar, Punjab, India
| | - Varun Pushkarna
- Department of Critical Care, Fortis Escort Hospital, Amritsar, Punjab, India
| | - Ruchi Gupta
- Department of Anaesthesia, SGRDIMSAR, Amritsar, Punjab, India
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Jokelainen J, Mustonen H, Kylänpää L, Udd M, Lindström O, Pöyhiä R. Assessment of sedation level for endoscopic retrograde cholangiopancreatography - a prospective validation study. Scand J Gastroenterol 2018; 53:370-375. [PMID: 29411681 DOI: 10.1080/00365521.2018.1435715] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND AND AIMS There is no consensus on how to assess the depth of sedation for endoscopic retrograde cholangiopancreatography (ERCP). This study was carried out in order to evaluate different methods of assessment of depth of sedation: bispectral index (BiS), modified Richmond Agitation/Sedation Scale (mRASS), modified Ramsay Sedation Scale (mRSS) and modified Observer Assessment of Alertness and Sedation (mOAAS) and their applicability to clinical practice. METHODS Two hundred patients were recruited. Sedation was given by standard clinical practice using propofol sedation or patient controlled sedation. Sedation was assessed on all patients using the above-mentioned methods. BiS was considered the reference point for sedation scales. Cronbach's alpha was calculated to determine the consistency of different scales in respect to each other and prediction probability and Spearman's correlation coefficients of sedation scales were calculated to show the relationship between sedation scales and BiS. RESULTS All scales showed high reliability with overall Cronbach's alpha 0.943. Dropping scales suggested better consistency between mOAAS, mRSS and mRASS than with BiS. Spearman's correlation and prediction probability showed similar results with all tested scales: mOAAS (0.695, 0.739), mRSS (0.673, 0.735), mRASS (0.683, 0.738), p < .01 for all scales. CONCLUSIONS All tested methods were found to be reliable in the assessment of the depth of sedation when compared with each other. However, mRASS, mRSS and mOAAS require the patient to respond to verbal or tactile stimulus, which may impair execution of ERCP, whereas BiS information is collected directly from electroencephalogram and thus may be preferable in clinical setting.
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Affiliation(s)
- Jarno Jokelainen
- a Department of Anesthesia and Intensive Care Medicine , South Karelia Central Hospital , Lappeenranta , Finland.,b Faculty of Medicine, University of Helsinki , Helsinki , Finland
| | - Harri Mustonen
- c Department of Gastroenterological and General Surgery , Helsinki University Hospital, University of Helsinki , Helsinki , Finland
| | - Leena Kylänpää
- c Department of Gastroenterological and General Surgery , Helsinki University Hospital, University of Helsinki , Helsinki , Finland
| | - Marianne Udd
- c Department of Gastroenterological and General Surgery , Helsinki University Hospital, University of Helsinki , Helsinki , Finland
| | - Outi Lindström
- c Department of Gastroenterological and General Surgery , Helsinki University Hospital, University of Helsinki , Helsinki , Finland
| | - Reino Pöyhiä
- b Faculty of Medicine, University of Helsinki , Helsinki , Finland.,d Kauniala Hospital , Kauniainen , Finland
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Ekmekçi P, Erkan G, Yilmaz H, K Kazbek B, C Köksoy U, Doganay G, Filiz Tüzüner D. Effect of Different Sedation Regimes on Cognitive Functions in Colonoscopy. Euroasian J Hepatogastroenterol 2017; 7:158-162. [PMID: 29201800 PMCID: PMC5670261 DOI: 10.5005/jp-journals-10018-1239] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/22/2017] [Accepted: 06/04/2017] [Indexed: 01/14/2023] Open
Abstract
Aim: To compare the effects of propofol/remifentanil and meperidine/midazolam on postprocedure cognitive function. Materials and methods: A total of 100 American Society of Anesthesiologists (ASA) score I to III patients undergoing elective colonoscopy were taken into the study and divided into two groups. Exclusion criteria were patient refusal, mini mental test (MMT) <26, The Amsterdam Preoperative Anxiety and Information Scale (APAIS) >10, advanced cardiopulmonary or psychiatric disease, chronic alcohol abuse, morbid obesity, and known allergy to study drugs. In group MM, 2 mg midazolam and 20 mg meperidine was given intravenously and additional 1 to 2 mg midazolam and 20 mg meperidine (with a maximum total of 5 mg midazolam and 50 mg meperidine) was given when bispectral index (BIS) was >80. In group RP, 100 μg/kg/minute propofol infusion and 1 μg/kg remifentanil bolus was administered and additional 0.5 μg/kg remifentanil bolus was given when BIS was >80. Observer’s Assessment of Alertness/Sedation scale (OAA/S) and Facial Pain Score (FPS) values were recorded. Cognitive function was measured by Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST). Results: The study was concluded with 100 patients. Heart rate was slower and BIS values were lower in group RP throughout the procedure. Blood pressure was lower in group RP without clinical significance. There was no difference concerning recovery time and visual analog scores (VASs). In group MM, TDT scores were higher and DSST scores were lower. Satisfaction was higher in group RP. Conclusion: Propofol/remifentanil combination is better than meperidine/midazolam combination concerning cognitive function in sedation for colonoscopy. Clinical significance: The addition of BIS monitorization to evaluate the depth of sedation and the negative effects of midazolam meperidine combination on postprocedural cognitive function. How to cite this article: Ekmekci P, Erkan G, Yilmaz H, Kazbek BK, Koksoy UC, Doganay G, Tüzüner F. Effect of Different Sedation Regimes on Cognitive Functions in Colonoscopy. Euroasian J Hepato-Gastroenterol 2017;7(2):158-162.
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Affiliation(s)
- Perihan Ekmekçi
- Department of Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
| | - Gulbanu Erkan
- Department of Gastroenterology, Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
| | - Hakan Yilmaz
- Department of Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
| | - Baturay K Kazbek
- Department of Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
| | - Ulku C Köksoy
- Department of Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
| | - Güler Doganay
- Department of Anesthesiology and Reanimation, Ufuk University, Ankara, Turkey
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Motiaa Y, Bensghir M, Jaafari A, Meziane M, Ahtil R, Kamili ND. Anesthesia for endoscopic retrograde cholangiopancreatography: target-controlled infusion versus standard volatile anesthesia. Ann Gastroenterol 2016; 29:530-535. [PMID: 27708522 PMCID: PMC5049563 DOI: 10.20524/aog.2016.0071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/27/2016] [Accepted: 06/12/2016] [Indexed: 11/11/2022] Open
Abstract
BACKGROUND Endoscopic retrograde cholangiopancreatography (ERCP) is a technique used both for diagnosis and for the treatment of biliary and pancreatic diseases. ERCP has some anesthetic implications and specific complications. The primary outcome aim was to compare two protocols in terms of time of extubation. We also compared anesthetic protocols in terms of hemodynamic and respiratory instability, antispasmodics needs, endoscopist satisfaction, and recovery room stay. METHODS Patients were randomized into two groups standard anesthesia group (Gr: SA) in whom induction was done by propofol, fentanyl and cisatracurium and maintenance was done by a mixture of oxygen, nitrousoxide (50%:50%) and sevoflurane; and intravenous anesthesia group to target concentration (Gr: TCI) in whom induction and maintenance of anesthesia were done with propofol with a target 0.5-2 μg/mL, and remifentanil with a target of 0.75-2 ng/mL. RESULTS 90 patients were included. Extubation time was shorter in Gr: TCI, 15±2.6 vs. 27.4±7.1 min in Gr: SA (P<0.001). The incidence of hypotension was higher in GrL: SA (P=0.009). Satisfaction was better in Gr: TCI (P=0.003). Antispasmodic need was higher in Gr: SA (P=0.023). Six patients in Gr: SA group had desaturation in post-anesthesia care unit (PACU) versus one patient from Gr: TCI (P=0.049). Patients in Gr: TCI had shorter PACU stay 40.2±7.3 vs. 58.7±12.4 min (P<0.001). CONCLUSION The use of TCI mode allows better optimization of general anesthesia technique during ERCP.
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Affiliation(s)
- Youssef Motiaa
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
| | - Mustapha Bensghir
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
| | - Abdelhamid Jaafari
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
| | - Mohammed Meziane
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
| | - Redouane Ahtil
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
| | - Noureddine Drissi Kamili
- Department of Anesthesiology and Critical Care, Mohamed V Military Hospital of Instruction, Faculty of Medicine and Pharmacy of Rabat, Mohamed V. University, Morocco
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Knežević A, Stojšić M, Gvozdenović L. Safety and clinical effectiveness of propofol for endoscopic retrograde cholangiopancreatography. Eur J Intern Med 2016; 32:e25. [PMID: 27021472 DOI: 10.1016/j.ejim.2016.03.003] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/28/2016] [Accepted: 03/01/2016] [Indexed: 11/16/2022]
Affiliation(s)
- Aleksandar Knežević
- Clinical Center of Vojvodina, Novi Sad, Serbia; School of Medicine, Novi Sad, Serbia
| | - Mirjana Stojšić
- Institute for Youth and Child Health Care of Vojvodina, Novi Sad, Serbia; School of Medicine, Novi Sad, Serbia
| | - Ljiljana Gvozdenović
- Clinical Center of Vojvodina, Novi Sad, Serbia; School of Medicine, Novi Sad, Serbia.
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Abstract
Gastrointestinal endoscopic sedation has improved procedural and patient outcomes but is associated with attendant risks of oversedation and hemodynamic compromise. Therefore, close monitoring during endoscopic procedures using sedation is critical. This monitoring begins with appropriate staff trained in visual assessment of patients and analysis of basic physiologic parameters. It also mandates an array of devices widely used in practice to evaluate hemodynamics, oxygenation, ventilation, and depth of sedation. The authors review the evidence behind monitoring practices and current society recommendations and discuss forthcoming technologies and techniques that are poised to improve noninvasive monitoring of patients under endoscopic sedation.
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Affiliation(s)
- Nadim Mahmud
- Department of Internal Medicine, Brigham and Women's Hospital, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA
| | - Tyler M Berzin
- Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, MA, USA.
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Conway A, Sutherland J. Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis. Int J Nurs Stud 2016; 63:201-212. [PMID: 27236824 DOI: 10.1016/j.ijnurstu.2016.05.004] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/25/2016] [Revised: 05/03/2016] [Accepted: 05/04/2016] [Indexed: 12/15/2022]
Abstract
OBJECTIVES Processed electroencephalogram-based depth of anaesthesia monitoring devices provide an additional method to monitor level of consciousness during procedural sedation and analgesia. The objective of this systematic review was to determine whether using a depth of anaesthesia monitoring device improves the safety and efficacy of sedation. DESIGN Systematic review and meta-analysis. DATA SOURCES Electronic databases (CENTRAL; Medline; CINAHL) were searched up to May 2015. REVIEW METHODS Randomised controlled trials that compared use of a depth of anaesthesia monitoring device to a control group who received standard monitoring during procedural sedation and analgesia were included. Study selection, data extraction and risk of bias assessment (Cochrane risk of bias tool) were performed by two reviewers. Safety outcomes were hypoxaemia, hypotension and adverse events. Efficacy outcomes were amount of sedation used, duration of sedation recovery and rate of incomplete procedures. RESULTS A total of 16 trials (2138 participants) were included. Evidence ratings were downgraded to either low or moderate quality due to study limitations and imprecision. Meta-analysis of 8 trials (766 participants) found no difference in hypoxaemia (RR 0.87; 95% CI=0.67-1.12). No statistically significant difference in hypotension was observed in meta-analysis of 8 trials (RR 0.96; 95% CI=0.54-1.7; 942 participants). Mean dose of propofol was 51mg lower for participants randomised to depth of anaesthesia monitoring (95% CI=-88.7 to -13.3mg) in meta-analysis of results from four trials conducted with 434 participants who underwent interventional endoscopy procedures with propofol infusions to maintain sedation. The difference in recovery time between depth of anaesthesia and standard monitoring groups was not clinically significant (standardised mean difference -0.41; 95% CI=-0.8 to -0.02; I2=86%; 8 trials; 809 participants). CONCLUSIONS Depth of anaesthesia monitoring did impact sedation titration during interventional procedures with propofol infusions. For this reason, it seems reasonable for anaesthetists to utilise a depth of anaesthesia monitoring device for select populations of patients if it is decided that limiting the amount of sedation would be beneficial for the individual patient. However, there is no need to invest in purchasing extra equipment or training staff who are not familiar with this technology (e.g. nurses who do not routinely use a depth of anaesthesia monitoring device during general anaesthesia) because there is no high quality evidence suggestive of clear clinical benefits for patient safety or sedation efficacy.
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Affiliation(s)
- Aaron Conway
- Queensland University Technology (QUT), Institute of Health & Biomedical Innovation, Kelvin Grove Campus, Kelvin Grove, QLD 4059, Australia; Cardiac Catheter Theatres, The Wesley Hospital, Auchenflower, QLD, Australia.
| | - Joanna Sutherland
- Coffs Harbour Health Campus, Australia; Rural Clinical School University of New South Wales, Australia.
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Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review. Anesth Analg 2016; 122:152-70. [PMID: 26678470 DOI: 10.1213/ane.0000000000000934] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.
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Gotoda T, Okada H, Hori K, Kawahara Y, Iwamuro M, Abe M, Kono Y, Miura K, Kanzaki H, Kita M, Kawano S, Yamamoto K. Propofol sedation with a target-controlled infusion pump and bispectral index monitoring system in elderly patients during a complex upper endoscopy procedure. Gastrointest Endosc 2016; 83:756-764. [PMID: 26301406 DOI: 10.1016/j.gie.2015.08.034] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/16/2015] [Accepted: 08/06/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Although the usefulness of propofol sedation during endoscopic submucosal dissection (ESD) for gastric neoplasms was reported previously, information is limited on its use in elderly patients. We investigated the safety and efficacy of propofol sedation with a target-controlled infusion (TCI) pump and bispectral index (BIS) monitoring system (TCI/BIS system) in elderly patients during gastric ESD. METHODS Included were 413 consecutive gastric ESD procedures involving 455 lesions (379 patients) performed in patients under propofol sedation with a TCI/BIS system between October 2009 and September 2013. Patients were divided into 3 groups: group A, age <70 years (n = 162); group B, age ≥70 and <80 years (n = 171); and group C, age ≥80 years (n = 80). We compared the propofol dose and adverse events (eg, hypotension and hypoxemia) during ESD. RESULTS Older groups required a lower target concentration of propofol (group A: median 2.1 μg/mL [interquartile range (IQR), 1.9-2.3]; group B: median 1.6 μg/mL [IQR, 1.3-1.8]; and group C: median 1.4 μg/mL [IQR, 1.2-1.6]; P < .0001). Hypotension tended to occur in the younger group, and hypoxemia occurred at a significantly higher rate in the older groups, although the number of cases was small. Low preoperative systolic blood pressure (≤125 mm Hg) was associated with hypotension (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.12-2.70; P = .013) and abnormal pulmonary function was associated with hypoxemia in groups B and C (OR, 4.54; 95% CI, 1.01-31.5; P = .048). CONCLUSIONS Elderly patients required lower doses of propofol with the TCI/BIS system than younger patients. Attention to hypoxemia is necessary in elderly patients, particularly patients with abnormal pulmonary function.
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Affiliation(s)
- Tatsuhiro Gotoda
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Hiroyuki Okada
- Department of Endoscopy, Okayama University Hospital, Okayama, Japan
| | - Keisuke Hori
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Yoshiro Kawahara
- Department of Endoscopy, Okayama University Hospital, Okayama, Japan
| | - Masaya Iwamuro
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Makoto Abe
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Yoshiyasu Kono
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Kou Miura
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Hiromitsu Kanzaki
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Masahide Kita
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Seiji Kawano
- Department of Endoscopy, Okayama University Hospital, Okayama, Japan
| | - Kazuhide Yamamoto
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
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Heo J, Jung MK, Lee HS, Cho CM, Jeon SW, Kim SK, Jeon YH. Effects of bispectral index monitoring as an adjunct to nurse-administered propofol combined sedation during colonoscopy: a randomized clinical trial. Korean J Intern Med 2016; 31:260-6. [PMID: 26932401 PMCID: PMC4773707 DOI: 10.3904/kjim.2014.077] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2014] [Revised: 02/11/2015] [Accepted: 04/05/2015] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND/AIMS The efficacy of bispectral index (BIS) monitoring during colonoscopic sedation is debated. We aimed to determine whether BIS monitoring was useful for propofol dose titration, and to evaluate differences in sedative administration between expert and inexperienced medical personnel during colonoscopy procedures that required moderate sedation. METHODS Between February 2012 and August 2013, 280 consecutive patients scheduled to undergo a screening colonoscopy participated in this study and were randomly allocated to the expert or inexperienced endoscopist group. Each group was further divided into either a BIS or a modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) subgroup. Trained nurses administered combined propofol sedation and monitored sedation using either the BIS or MOAA/S scale. RESULTS The mean BIS value throughout the procedure was 74.3 ± 6.7 for all 141 patients in the BIS group. The mean total propofol dose administered in the BIS group was higher than that in the MOAA/S group, independently of the endoscopists' experience level (36.9 ± 29.6 and 11.3 ± 20.7, respectively; p < 0.001). The total dose of propofol administered was not significantly different between the inexperienced endoscopist group and the expert endoscopist group, both with and without the use of BIS (p = 0.430 and p = 0.640, respectively). CONCLUSIONS Compared with monitoring using the MOAA/S score alone, BIS monitoring was not effective for titrating the dose of propofol during colonoscopy, irrespective of colonoscopist experience.
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Affiliation(s)
- Jun Heo
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
| | - Min Kyu Jung
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
- Correspondence to Min Kyu Jung, M.D. Department of Internal Medicine, Kyungpook National University School of Medicine, 680 Gukchaebosang-ro, Jung-gu, Daegu 41944, Korea Tel: +82-53-420-5514 Fax: +82-53-426-8773 E-mail:
| | - Hyun Seok Lee
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
| | - Chang Min Cho
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
| | - Seong Woo Jeon
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
| | - Sung Kook Kim
- Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Korea
| | - Young Hoon Jeon
- Department of Anesthesiology and Pain Medicine, Kyungpook National University School of Medicine, Daegu, Korea
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Bispectral Index Versus Standard Monitoring in Sedation for Endoscopic Procedures: A Systematic Review and Meta-Analysis. Dig Dis Sci 2016; 61:814-24. [PMID: 26531839 DOI: 10.1007/s10620-015-3945-9] [Citation(s) in RCA: 31] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/13/2015] [Accepted: 10/22/2015] [Indexed: 01/30/2023]
Abstract
BACKGROUND Bispectral index (BIS ) monitoring has been used as an objective measurement tool for sedation depth and has been proposed as a guidance to reduce the risk of intraprocedural over-sedation. However, the results of several studies evaluating the benefits of BIS monitoring for gastrointestinal endoscopy were not consistent. AIMS This meta-analysis aimed to assess the reduction in total consumption of administrated propofol and recovery time under BIS during gastrointestinal endoscopy. METHODS Electronic databases (MEDLINE, EMBASE, WEB of SCIENCE, and the Cochrane Central Register of Controlled Trials) were searched for articles published through March 2015. After screening, the reviewers extracted information on 11 randomized controlled trials. A total of 1039 patients (526 in BIS and 513 in non-BIS group) were included in this study. RESULTS Meta-analyses showed that the total propofol consumption (the pooled standardized mean difference [SMD]: -0.15, 95% confidence interval [CI]: -0.28 to -0.01) was significantly lower in the BIS group than in the non-BIS group, although mean propofol consumption was not significantly different. Recovery time (the pooled SMD: -0.04 [95% CI -0.46 to 0.38, P = 0.85]), procedure time (the pooled SMD: 0.13 [95% CI -0.03 to 0.29, P = 0.11]), adverse events, and satisfaction-related outcomes were not significantly superior in the BIS group when compared with the non-BIS group. CONCLUSIONS This first meta-analysis showed that BIS monitoring appears to be an effective and safe method for avoiding unnecessary administration of propofol and for providing adequate sedation during endoscopic procedures.
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Safety of Non-anesthesia Provider-Administered Propofol (NAAP) Sedation in Advanced Gastrointestinal Endoscopic Procedures: Comparative Meta-Analysis of Pooled Results. Dig Dis Sci 2015; 60:2612-27. [PMID: 25732719 DOI: 10.1007/s10620-015-3608-x] [Citation(s) in RCA: 52] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2015] [Accepted: 02/21/2015] [Indexed: 12/14/2022]
Abstract
BACKGROUND AND AIMS The aim of the study was to evaluate the safety of non-anesthesia provider (NAAP)-administered propofol sedation for advanced endoscopic procedures with those of anesthesia provider (AAP). METHODS PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science databases were searched for prospective observational trials involving advanced endoscopic procedures. From a total of 519 publications, 26 were identified to meet inclusion criteria (10 AAPs and 16 NAAPs) and were analyzed. Data were analyzed for hypoxia rate, airway intervention rates, endoscopist, and patient satisfaction scores and total propofol administered. RESULTS Total number of procedures in NAAP and AAP groups was 3018 and 2374, respectively. Pooled hypoxia (oxygen saturation less than 90 %) rates were 0.133 (95 % CI 0.117-0.152) and 0.143 (95 % CI 0.128-0.159) in NAAP and AAP, respectively. Similarly, pooled airway intervention rates were 0.035 (95 % CI 0.026-0.047) and 0.133 (95 % CI 0.118-0.150), respectively. Pooled patient satisfaction rate, pooled endoscopist satisfaction rate, and mean propofol administered dose for NAAP were 7.22 (95 % CI 7.17-7.27), 6.03 (95 % CI 5.94-6.11), and 251.44 mg (95 % CI 244.39-258.49) in that order compared with 9.82 (95 % CI 9.76-9.88), 9.06 (95 % CI 8.91-9.21), and 340.32 mg (95 % CI 327.30-353.33) for AAP. CONCLUSIONS The safety of NAAP sedation compared favorably with AAP sedation in patients undergoing advanced endoscopic procedures. However, it came at the cost of decreased patient and endoscopist satisfaction.
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Optimization of Deep Sedation with Spontaneous Respiration for Therapeutic Endoscopy Combining Propofol and Bispectral Index Monitoring. Gastroenterol Res Pract 2015; 2015:282149. [PMID: 26351450 PMCID: PMC4550768 DOI: 10.1155/2015/282149] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2015] [Revised: 07/30/2015] [Accepted: 08/04/2015] [Indexed: 02/06/2023] Open
Abstract
Background/Aims. This study aimed to establish optimal propofol anesthesia for therapeutic endoscopy, which has not been established. Methodology. We retrospectively investigated data on 89 patients who underwent upper-GI endoscopic submucosal dissection or endoscopic mucosal resection under anesthesia with propofol. Examined doses of propofol were changed according to efficacy and/or adverse events and classified into 5 periods. A bispectral index (BIS) monitor was used at Period 5 to decrease the incidence of adverse events caused by oversedation. The initial dose of propofol was administered after bolus injection of pethidine hydrochloride (0.5 mg/kg), and 1.0 mL of propofol was added every minute until the patients fell asleep. Continuous and bolus infusion were performed to maintain sedation. When the patient moved or an adverse event occurred, the maintenance dose examined was increased or decreased by 5 mL/h regardless of body weight. Results. Dose combinations (introduction : maintenance) and patient numbers for each period were as follows: Period 1 (n = 27), 0.5 mg/kg : 5 mg/kg/h; Period 2 (n = 11), 0.33 mg/kg : 3.3 mg/kg/h; Period 3 (n = 7), 0.5 mg/kg : 3.3 mg/kg/h; Period 4 (n = 14), 0.5 mg/kg : 2.5 mg/kg/h; Period 5 (n = 30), 0.5 mg/kg : 2.5 mg/kg/h, using BIS monitor. During Period 5, an adverse event occurred in 10.0% of patients, which was lower than that for Periods 1–4. Conclusions. Period 5 propofol anesthesia with BIS protocol could be safe and useful for therapeutic endoscopy under deep sedation with spontaneous respiration.
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Kawano S, Okada H, Iwamuro M, Kouno Y, Miura K, Inokuchi T, Kanzaki H, Hori K, Harada K, Hiraoka S, Kawahara Y, Yamamoto K. An effective and safe sedation technique combining target-controlled infusion pump with propofol, intravenous pentazocine, and bispectral index monitoring for peroral double-balloon endoscopy. Digestion 2015; 91:112-116. [PMID: 25677385 DOI: 10.1159/000369614] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2014] [Accepted: 11/11/2014] [Indexed: 02/04/2023]
Abstract
BACKGROUND/AIMS Because peroral double-balloon endoscopy (DBE) is a time-consuming, painful procedure, sedation with analgesics, and/or anesthetics is generally required. The aim of this prospective study was to investigate the safety and efficacy of our sedation protocol for peroral DBE, which consisted of target-controlled infusion (TCI) anesthesia with propofol, an intravenous bolus of pentazocine, and bispectral index (BIS) monitoring. METHODS A total of 34 consecutive patients who underwent DBE by the oral approach were enrolled. Patients were primarily sedated with a continuous infusion of propofol and adjusted in accordance with the BIS levels. The bolus infusion of pentazocine was performed when the propofol infusion was insufficient. The primary outcome measure of this study was to ensure the safety and efficacy of this sedation technique. The secondary purpose was to identify the characteristics of the patient who required the bolus infusion of pentazocine. RESULTS Five patients (14.7%) required a reduction in the dose of propofol. However, no patient experienced any serious adverse events. All patients (100%) and 80.6% (25/31) of endoscopists answered that the sedation protocol was 'excellent' or 'enough' for peroral DBE. Eleven patients (32.3%) required a bolus injection of pentazocine. Age <60 years and a total procedure time of >70 min were significant risk-factors for pentazocine use. CONCLUSIONS A combination of propofol via TCI pump, bolus injection of pentazocine as needed, and BIS monitoring was a safe and effective procedure for peroral DBE. Reasonable satisfaction indices were obtained from both patients and endoscopists. Pentazocine was required for young patients and in cases with longer procedure times.
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Affiliation(s)
- Seiji Kawano
- Department of Endoscopy, Okayama University Hospital, Okayama, Japan
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Imagawa A, Hata H, Nakatsu M, Matsumi A, Ueta E, Suto K, Terasawa H, Sakae H, Takeuchi K, Fujihara M, Endo H, Yasuhara H, Ishihara S, Kanzaki H, Jinno H, Kamada H, Kaji E, Moriya A, Ando M. A target-controlled infusion system with bispectral index monitoring of propofol sedation during endoscopic submucosal dissection. Endosc Int Open 2015; 3:E2-E6. [PMID: 26134767 PMCID: PMC4423246 DOI: 10.1055/s-0034-1377519] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2014] [Accepted: 06/11/2014] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND AND STUDY AIMS Propofol administration via a target-controlled infusion system with bispectral index monitoring (BIS/TCI system) is expected to prevent complications from sedation during complex and long endoscopic procedures. We evaluated the feasibility of setting the BIS/TCI system for non-anesthesiologist administration of propofol (NAAP) during endoscopic submucosal dissection (ESD). PATIENTS AND METHODS From May 2009 to February 2013, 250 patients with esophagogastric neoplasms were treated with ESD using the BIS/TCI system with NAAP. In the TCI system, the initial target blood concentration of propofol was set at 1.2 μg/mL. The titration speed of propofol was adjusted according to the BIS score and the movement of the patient. The BIS target level ranged from moderate to deep sedation, at which a stable BIS score between 60 and 80 was obtained. RESULTS In 80.4 % of patients, it was possible to maintain stable sedation with a blood concentration of propofol of less than 1.6 µg/mL using TCI throughout the ESD procedure. The default setting for ideal blood concentration of propofol was 1.2 μg/mL, because the medians of the lower and upper bounds of blood concentration were 1.2 μg/mL (range 0.6 - 1.8 μg/mL) and 1.4 μg/mL (range 1.0 - 3.8 μg/mL), respectively. Although hypotension occurred in 27 patients (10.8 %), oxygen desaturation occurred in only nine patients (3.6 %), and severe desaturation in only two patients (0.8 %). CONCLUSIONS Using our settings, it is possible for a non-anesthesiologist to maintain stable sedation during a lengthy endoscopic procedure through propofol sedation with a BIS/TCI system.
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Affiliation(s)
- Atsushi Imagawa
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hidenori Hata
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Morihito Nakatsu
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Akihiro Matsumi
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Eijiro Ueta
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Kozue Suto
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hiroyuki Terasawa
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hiroyuki Sakae
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Keiko Takeuchi
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Manabu Fujihara
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hitomi Endo
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hisae Yasuhara
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Shinichi Ishihara
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hiromitsu Kanzaki
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hideki Jinno
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Hidenori Kamada
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Eisuke Kaji
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Akio Moriya
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
| | - Masaharu Ando
- Department of Gastroenterology, Mitoyo General Hospital, Kagawa, Japan
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Park WY, Shin YS, Lee SK, Kim SY, Lee TK, Choi YS. Bispectral index monitoring during anesthesiologist-directed propofol and remifentanil sedation for endoscopic submucosal dissection: a prospective randomized controlled trial. Yonsei Med J 2014; 55:1421-9. [PMID: 25048506 PMCID: PMC4108833 DOI: 10.3349/ymj.2014.55.5.1421] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
PURPOSE Endoscopic submucosal dissection (ESD) is a technically difficult and lengthy procedure requiring optimal depth of sedation. The bispectral index (BIS) monitor is a non-invasive tool that objectively evaluates the depth of sedation. The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol, and thus reduce the incidence of sedation- and/or procedure-related complications. MATERIALS AND METHODS A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups. The control group (n=90) was monitored by the Modified Observer's Assessment of Alertness and Sedation scale and the BIS group (n=90) was monitored using BIS. The total doses of propofol and remifentanil, the need for rescue propofol, and the rates of complications were recorded. RESULTS The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group (47.8% vs. 30.0%, p=0.014). There were no significant differences in the incidence of sedation- and/or procedure-related complications. CONCLUSION BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures. However, this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation.
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Affiliation(s)
- Woo Young Park
- Department of Anesthesiology and Pain Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
| | - Yang-Sik Shin
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
| | - Sang Kil Lee
- Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - So Yeon Kim
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
| | - Tai Kyung Lee
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea
| | - Yong Seon Choi
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea.
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Yang KS, Habib AS, Lu M, Branch MS, Muir H, Manberg P, Sigl JC, Gan TJ. A prospective evaluation of the incidence of adverse events in nurse-administered moderate sedation guided by sedation scores or Bispectral Index. Anesth Analg 2014; 119:43-48. [PMID: 24413547 DOI: 10.1213/ane.0b013e3182a125c3] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
BACKGROUND Moderate sedation is routinely performed in patients undergoing minor therapeutic and diagnostic procedures outside the operating room. The level of sedation is often monitored by sedation nurses using clinical criteria, such as sedation scores. The Bispectral Index (BIS) is derived from changes in the electroencephalograph profile that may provide an objective measure of the level of sedation. In this prospective observational study, we investigated whether using BIS values to guide sedative drug administration influences the level of sedation and the incidence of adverse events compared with using Ramsay sedation scale (RSS) only in nurse-administered moderate sedation. We hypothesized that both depth of sedation and the incidence of adverse events related to oversedation would decrease when sedation nurses used BIS values to help guide sedative drug administration. METHODS Sedation care was provided by trained sedation nurses under the supervision of a physician performing the procedure. The sedation regimen was initiated with IV midazolam 1 to 2 mg and fentanyl 50 mcg or hydromorphone 0.2 mg. Additional small boluses of midazolam, fentanyl, or hydromorphone were administered to maintain an RSS of 2 to 3 (cooperative, oriented, and responding to verbal command). Propofol was not used. Information including patient demographics, type of procedure, medication administered, RSS, and rates of adverse events was recorded by the sedation nurses for each patient on a computer-readable form. The study was divided into 3 phases. In phase 1 (baseline, 6 months' duration), baseline data on sedation practice were prospectively collected. There was no change from standard of care for all patients except that each patient had a BIS sensor attached, but the monitor was covered and nurses were blinded to the BIS values. In phase 2 (training, 3 months), the sedation nurses received comprehensive education on the use of BIS to guide sedative drug administration, pharmacology of commonly used drugs, and methods for rescue from oversedation. The recommended BIS range for moderate sedation was 75 to 90. Adequate training of all sedation nurses on the use of BIS was documented. In phase 3 (implementation, 6 months), the BIS values were used to guide drug administration. RESULTS Data were available on 1766 patients (999 and 767 patients in phases 1 and 3, respectively). Most of the procedures were colonoscopies, upper gastrointestinal endoscopies, examinations under anesthesia, endoscopic retrograde cholangiopancreatography, and central venous access catheter placements. No differences in the demographics between the 2 groups were observed. The RSS was inversely associated with the BIS value, r = -0.16 (95% confidence interval, -0.19 to -0.12; P < 0.00001). An RSS of 2 to 3 was maintained in 94% of patients in phase 1 and 96% of patients in phase 3 The mean (±SD) BIS values were 80.9 ± 6.8 in phase 1 and 80.4 ± 6.5 in phase 3. The number of sedation-related adverse events was lower in our sample when BIS was used, with an odds ratio of 0.41 (95% confidence interval, 0.28-0.62; P < 0.0001), and patients with restlessness had a lower BIS value than those without this symptom (P < 0.0001). No serious adverse events or deaths were reported. CONCLUSIONS Nurse-administered moderate sedation using midazolam and fentanyl was usually associated with appropriate levels of sedation as assessed by both the RSS and BIS with an overall low incidence of adverse events. The use of BIS did not change the mean level of sedation significantly, although the number of sedation-related adverse events appears to be lower when BIS was used.
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Affiliation(s)
- Katie S Yang
- From the *School of Medicine and the †Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; ‡Healthcare Economics & Outcomes Research, Covidien, Inc., Mansfield, Massachusetts; §Division of Gastroenterology, Duke University Medical Center, Durham, North Carolina; ‖Corolla Clin/Reg Consulting, Corolla, North Carolina; and ¶Advanced Research Group, Covidien, Mansfield, Massachusetts
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Lee TH, Lee CK. Endoscopic sedation: from training to performance. Clin Endosc 2014; 47:141-50. [PMID: 24765596 PMCID: PMC3994256 DOI: 10.5946/ce.2014.47.2.141] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2014] [Revised: 02/25/2014] [Accepted: 02/26/2014] [Indexed: 12/24/2022] Open
Abstract
Adequate sedation and analgesia are considered essential requirements to relieve patient discomfort and pain and ultimately to improve the outcomes of modern gastrointestinal endoscopic procedures. The willingness of patients to undergo sedation during endoscopy has increased steadily in recent years and standard sedation practices are needed for both patient safety and successful procedural outcomes. Therefore, regular training and education of healthcare providers is warranted. However, training curricula and guidelines for endoscopic sedation may have conflicts according to varying legal frameworks and/or social security systems of each country, and well-recognized endoscopic sedation training systems are not currently available in all endoscopy units. Although European and American curricula for endoscopic sedation have been extensively developed, general curricula and guidelines for each country and institution are also needed. In this review, an overview of recent curricula and guidelines for training and basic performance of endoscopic sedation is presented based on the current literature.
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Affiliation(s)
- Tae Hoon Lee
- Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - Chang Kyun Lee
- Division of Gastroenterology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, Korea
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Yu YH, Han DS, Kim HS, Kim EK, Eun CS, Yoo KS, Shin WJ, Ryu S. Efficacy of bispectral index monitoring during balanced propofol sedation for colonoscopy: a prospective, randomized controlled trial. Dig Dis Sci 2013; 58:3576-83. [PMID: 23982208 DOI: 10.1007/s10620-013-2833-4] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/24/2012] [Accepted: 07/31/2013] [Indexed: 12/17/2022]
Abstract
BACKGROUND AND AIMS Appropriate use of propofol is necessary, and objective monitoring of sedation with propofol may be helpful. Studies on the efficacy of bispectral index (BIS) monitoring in deep sedation have been conducted, but its efficacy in colonoscopy with moderate sedation is unknown. In this study, the efficacy of BIS monitoring during colonoscopy with moderate level sedation via balanced propofol sedation was investigated. METHODS To determine the cut-off value of BIS before the test, an optimal BIS value was determined. Patients who were scheduled to undergo outpatient colonoscopy were prospectively randomized to either a BIS or control group. Finally, a total of 115 patients were selected for this study. The satisfaction level, the complication, and the dosage of the administered propofol were compared. RESULTS The BIS values and the modified observer's assessment of alertness/sedation scores (MOAA/S) were positively correlated (r=0.66 and p<0.001). The optimal cut-off value of BIS for maintaining moderate sedation was 81, and the area under the ROC curve was 0.88 (95% CI 0.82-0.93), indicating high prediction accuracy. However, there was no difference between the BIS group and the control group in levels of satisfaction of either patients or endoscopists. In addition, there was no difference in the complication and the required dose of propofol between both groups. CONCLUSIONS BIS and clinical sedation scores, MOAA/S scores, showed a high level of correlation. However, no significant efficacy was observed in the BIS group who underwent outpatient colonoscopy.
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Affiliation(s)
- Yeon Hwa Yu
- Department of Internal Medicine, Seoul Metropolitan Dongbu Hospital, Seoul, Korea
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Deep sedation without intubation for ERCP is appropriate in healthier, non-obese patients. Dig Dis Sci 2013; 58:3287-92. [PMID: 23877477 DOI: 10.1007/s10620-013-2783-x] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/13/2013] [Accepted: 06/28/2013] [Indexed: 12/09/2022]
Abstract
BACKGROUND Providing the appropriate anesthesia for endoscopic retrograde cholangiopancreatography (ERCP) cases is challenging. AIM The aim of our study was to prospectively assess the safety of anesthesia directed deep sedation (ADDS) in non-intubated patients compared to general endotracheal anesthesia (GET) during an ERCP. METHODS We conducted a prospective observational study in patients undergoing an ERCP. The choice of anesthetic-ADDS or GET-was made by the anesthesiologist. The pre-anesthesia assessment, intraoperative vital signs, and medications administered were collected. A standardized study instrument was used to record the number of procedure interruptions, intraprocedure and recovery room adverse events (AE). RESULTS A total of 393 (89.7 %) patients received ADDS (no intubation) and 45 (10.2 %) received a GET. Age and comorbidities were similar in ADDS and GET groups. BMI was higher in the GET (32.6 ± 9.5) versus in the ADDS (27.3 ± 6.1) group; p < 0.001. The number of ASA 2 patients was higher in the ADDS versus the GET group (38.7 versus 22.2 %; p < 0.04); the number of ASA 4 patients was 15.6 % of GET versus 6.6 % of the ADDS cases (p = 0.05). During the procedure 16 (3.7 %) ADDS patients were intubated and converted to a GET anesthetic; 4 (25 %) of the converted ADDS cases were ASA 4 versus 6.4 % of ADDS patients (p = 0.006). Intraprocedure events occurred in 35.6 % of GET and 25.7 % of ADDS cases, without significant complications. CONCLUSION Our data suggest that the administration of anesthesia without intubation for prone ERCP cases is feasible especially in non-obese, healthier patients.
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Alados-Arboledas F, Millán-Bueno M, Expósito-Montes J, Santiago-Gutierrez C, Arévalo-Garrido A, Pérez-Parras A, Millán-Miralles L, Martínez-Padilla M, de la Cruz-Moreno J. Utilidad de la monitorización anestésica con el índice biespectral en endoscopias digestivas altas en respiración espontánea. An Pediatr (Barc) 2013; 79:83-7. [DOI: 10.1016/j.anpedi.2012.11.019] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/13/2012] [Revised: 10/24/2012] [Accepted: 11/16/2012] [Indexed: 12/17/2022] Open
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Santos MELD, Maluf-Filho F, Chaves DM, Matuguma SE, Ide E, Luz GDO, Souza TFD, Pessorrusso FCS, Moura EGHD, Sakai P. Deep sedation during gastrointestinal endoscopy: propofol-fentanyl and midazolam-fentanyl regimens. World J Gastroenterol 2013; 19:3439-46. [PMID: 23801836 PMCID: PMC3683682 DOI: 10.3748/wjg.v19.i22.3439] [Citation(s) in RCA: 36] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/03/2012] [Revised: 12/22/2012] [Accepted: 01/11/2013] [Indexed: 02/06/2023] Open
Abstract
AIM To compare deep sedation with propofol-fentanyl and midazolam-fentanyl regimens during upper gastrointestinal endoscopy. METHODS After obtaining approval of the research ethics committee and informed consent, 200 patients were evaluated and referred for upper gastrointestinal endoscopy. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation using the observer's assessment of alertness/sedation (OAA/S) score and bispectral index (BIS). We evaluated patient and physician satisfaction, as well as the recovery time and complication rates. The statistical analysis was performed using SPSS statistical software and included the Mann-Whitney test, χ² test, measurement of analysis of variance, and the κ statistic. RESULTS The times to induction of sedation, recovery, and discharge were shorter in the propofol-fentanyl group than the midazolam-fentanyl group. According to the OAA/S score, deep sedation events occurred in 25% of the propofol-fentanyl group and 11% of the midazolam-fentanyl group (P = 0.014). Additionally, deep sedation events occurred in 19% of the propofol-fentanyl group and 7% of the midazolam-fentanyl group according to the BIS scale (P = 0.039). There was good concordance between the OAA/S score and BIS for both groups (κ = 0.71 and κ = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group and 26% of the midazolam-fentanyl group (P = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (P < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination. CONCLUSION Deep sedation occurred with propofol-fentanyl and midazolam-fentanyl, but was more frequent in the former. Recovery was faster in the propofol-fentanyl group.
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Wang D, Chen C, Chen J, Xu Y, Wang L, Zhu Z, Deng D, Chen J, Long A, Tang D, Liu J. The use of propofol as a sedative agent in gastrointestinal endoscopy: a meta-analysis. PLoS One 2013; 8:e53311. [PMID: 23308191 PMCID: PMC3540096 DOI: 10.1371/journal.pone.0053311] [Citation(s) in RCA: 98] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/07/2012] [Accepted: 11/27/2012] [Indexed: 02/07/2023] Open
Abstract
OBJECTIVES To assess the efficacy and safety of propofol sedation for gastrointestinal endoscopy, we conducted a meta-analysis of randomized controlled trials (RCTs) comparing propofol with traditional sedative agents. METHODS RCTs comparing the effects of propofol and traditional sedative agents during gastrointestinal endoscopy were found on MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE. Cardiopulmonary complications (i.e., hypoxia, hypotension, arrhythmia, and apnea) and sedation profiles were assessed. RESULTS Twenty-two original RCTs investigating a total of 1,798 patients, of whom 912 received propofol only and 886 received traditional sedative agents only, met the inclusion criteria. Propofol use was associated with shorter recovery (13 studies, 1,165 patients; WMD -19.75; 95% CI -27.65, 11.86) and discharge times (seven studies, 471 patients; WMD -29.48; 95% CI -44.13, -14.83), higher post-anesthesia recovery scores (four studies, 503 patients; WMD 2.03; 95% CI 1.59, 2.46), better sedation (nine studies, 592 patients; OR 4.78; 95% CI 2.56, 8.93), and greater patient cooperation (six studies, 709 patients; WMD 1.27; 95% CI 0.53, 2.02), as well as more local pain on injection (six studies, 547 patients; OR 10.19; 95% CI 3.93, 26.39). Effects of propofol on cardiopulmonary complications, procedure duration, amnesia, pain during endoscopy, and patient satisfaction were not found to be significantly different from those of traditional sedative agents. CONCLUSIONS Propofol is safe and effective for gastrointestinal endoscopy procedures and is associated with shorter recovery and discharge periods, higher post-anesthesia recovery scores, better sedation, and greater patient cooperation than traditional sedation, without an increase in cardiopulmonary complications. Care should be taken when extrapolating our results to specific practice settings and high-risk patient subgroups.
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Affiliation(s)
- Daorong Wang
- Department of Gastrointestinal Surgery, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Chaowu Chen
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Jie Chen
- Department of Gastrointestinal Surgery, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Yaxiang Xu
- Department of Gastrointestinal Surgery, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Lu Wang
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Zhen Zhu
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Denghao Deng
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Juan Chen
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Aihua Long
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Dong Tang
- Department of Gastrointestinal Surgery, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
| | - Jun Liu
- Department of Gastroenterology, Subei People’s Hospital of Jiangsu Province (Clinical Medical College of Yangzhou University), Yangzhou, Jiangsu Province, People’s Republic of China
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Maple JT. Preparation for ERCP. ERCP 2013:73-79.e2. [DOI: 10.1016/b978-1-4557-2367-6.00009-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/04/2025]
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Jang SY, Park HG, Jung MK, Cho CM, Park SY, Jeon SW, Tak WY, Kweon YO, Kim SK, Jeon YH. Bispectral index monitoring as an adjunct to nurse-administered combined sedation during endoscopic retrograde cholangiopancreatography. World J Gastroenterol 2012; 18:6284-6289. [PMID: 23180950 PMCID: PMC3501778 DOI: 10.3748/wjg.v18.i43.6284] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To determine whether bispectral index (BIS) monitoring is useful for propofol administration for deep sedation during endoscopic retrograde cholangiopancreatography (ERCP).
METHODS: Fifty-nine consecutive patients with a variety of reasons for ERCP who underwent the procedure at least twice between 1 July 2010 and 30 November 2010. This was a randomized cross-over study, in which each patient underwent ERCP twice, once with BIS monitoring and once with control monitoring. Whether BIS monitoring was done during the first or second ERCP procedure was random. Patients were intermittently administered a mixed regimen including midazolam, pethidine, and propofol by trained nurses. The nurse used a routine practice to monitor sedation using the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale or the BIS monitoring. The total amount of midazolam and propofol used and serious side effects were compared between the BIS and control groups.
RESULTS: The mean total propofol dose administered was 53.1 ± 32.2 mg in the BIS group and 54.9 ± 30.8 mg in the control group (P = 0.673). The individual propofol dose received per minute during the ERCP procedure was 2.90 ± 1.83 mg/min in the BIS group and 3.44 ± 2.04 mg in the control group (P = 0.103). The median value of the MOAA/S score during the maintenance phase of sedation was comparable for the two groups. The mean BIS values throughout the procedure (from insertion to removal of the endoscope) were 76.5 ± 8.7 for all 59 patients in using the BIS monitor. No significant differences in the frequency of < 80% oxygen saturation, hypotension (< 80 mmHg), or bradycardia (< 50 beats/min) were observed between the two study groups. Four cases of poor cooperation occurred, in which the procedure should be stopped to add the propofol dose. After adding the propofol, the procedure could be conducted successfully (one case in the BIS group, three cases in the control group). The endoscopist rated patient sedation as excellent for all patients in both groups. All patients in both groups rated their level of satisfaction as high (no discomfort). During the post-procedural follow-up in the recovery area, no cases of clinically significant hypoxic episodes were recorded in either group. No other postoperative side effects related to sedation were observed in either group.
CONCLUSION: BIS monitoring trend to slighlty reduce the mean propofol dose. Nurse-administered propofol sedation under the supervision of a gastroenterologist may be considered an alternative under anesthesiologist.
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Chun SY, Kim KO, Park DS, Kim SY, Park JW, Baek IH, Kim JH, Park CK. Safety and efficacy of deep sedation with propofol alone or combined with midazolam administrated by nonanesthesiologist for gastric endoscopic submucosal dissection. Gut Liver 2012; 6:464-70. [PMID: 23170151 PMCID: PMC3493727 DOI: 10.5009/gnl.2012.6.4.464] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/03/2012] [Accepted: 06/22/2012] [Indexed: 12/26/2022] Open
Abstract
Background/Aims Endoscopic submucosal dissection (ESD) is accepted as a treatment for gastric neoplasms and usually requires deep sedation. The aim of this study was to evaluate the safety and efficacy profiles of deep sedation induced by continuous propofol infusion with or without midazolam during ESD. Methods A total of 135 patients scheduled for ESDs between December 2008 and June 2010 were included in this prospective study and were randomly assigned to one of two groups: the propofol group or the combination group (propofol plus midazolam). Results The propofol group reported only one case of severe hypoxemia with no need of mask ventilation or intubation. Additionally, 18 cases of mild hypotension were observed in the propofol group, and 11 cases were observed in the combination group. The combination group had a lower mean total propofol dose (378 mg vs 466 mg, p<0.012), a longer mean recovery time (10.5 minutes vs 7.9 minutes, p=0.027), and a lower frequency of overall adverse events (32.8% vs 17.6%, p=0.042). Conclusions Deep sedation induced by continuous propofol infusion was shown to be safe during ESD. The combination of continuous propofol infusion and intermittent midazolam injection can decrease the total dose and infusion rate of propofol and the overall occurrence of adverse events.
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Affiliation(s)
- Seung Yeon Chun
- Department of Internal Medicine, Hallym University College of Medicine, Anyang, Korea
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Abstract
Sedation is the drug-induced reduction of a patient's consciousness. The aim of sedation in endoscopic procedures is to increase the patient's comfort and to improve endoscopic performance, especially in therapeutic procedures. The most commonly used sedation regimen for conscious sedation in gastrointestinal endoscopy is still the combination of benzodiazepines with opioids. However, the use of propofol has increased enormously in the past decade and several studies show advantages of propofol over the traditional regimes in terms of faster recovery time. It is important to be aware that the complication rate of endoscopies increases when sedation is used; therefore, a thorough risk evaluation before the procedure and monitoring during the procedure must be performed. In addition, properly trained staff and emergency equipment should be available. The best approach to sedation in endoscopy is to choose a sedation regimen for the individual patient, tailored according to the clinical risk assessment and the anxiety level of the patient, as well as to the type of planned endoscopic procedure.
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European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol 2011; 27:1016-30. [PMID: 21068575 DOI: 10.1097/eja.0b013e32834136bf] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Propofol sedation by non-anaesthesiologists is an upcoming sedation regimen in several countries throughout Europe. Numerous studies have shown the efficacy and safety of this sedation regimen in gastrointestinal endoscopy. Nevertheless, this issue remains highly controversial. The aim of this evidence- and consensus-based set of guideline is to provide non-anaesthesiologists with a comprehensive framework for propofol sedation during digestive endoscopy. This guideline results from a collaborative effort from representatives of the European Society of Gastrointestinal Endoscopy (ESGE), the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) and the European Society of Anaesthesiology (ESA). These three societies have endorsed the present guideline.The guideline is published simultaneously in the Journals Endoscopy and European Journal of Anaesthesiology.
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