Safety and efficacy of remimazolam versus propofol during EUS: a multicenter randomized controlled study
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Updated: Jun 29, 2025
Drug-Induced Sleep Endoscopy DISE with Target Controlled Infusion TCI and Bispectral Analysis in Obstructive Sleep Apnea
Published on: December 6, 2016
Jung Wan Choe1, Moon Jae Chung2, Se Woo Park3
1Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.
Background And Aims:
Propofol, a widely used sedative in GI endoscopic procedures, is associated with cardiorespiratory suppression. Remimazolam is a novel ultrashort-acting benzodiazepine sedative with rapid onset and minimal cardiorespiratory depression. This study compared the safety and efficacy of remimazolam and propofol during EUS procedures.
Methods:
A multicenter randomized controlled study was conducted between October 2022 and March 2023 in patients who underwent EUS procedures. Patients were randomly assigned to receive either remimazolam or propofol as a sedative agent. The primary endpoint was cardiorespiratory adverse events (AEs) during the procedure, including desaturation, respiratory depression, hypotension, and tachycardia. Secondary endpoints were the time to achieve sedation, recovery time, quality of sedation, pain at the injection site, and satisfaction of both endoscopists and patients.
Results:
Four hundred patients enrolled in the study: 200 received remimazolam (10.8 ± 7.7 mg) and 200 received propofol (88.0 ± 49.1 mg). For cardiorespiratory AEs, the remimazolam group experienced fewer occurrences than the propofol group (8.5% vs 16%, P = .022). A nonsignificant trend was found toward less oxygen desaturation (1.0% vs 3.5%, P = .09), respiratory depression (.5% vs 1.5%, P = .62), hypotension (2.5% vs 5.5%, P = .12), and tachycardia (4.5% vs 5.5%, P = .68) with remimazolam than with propofol. Remimazolam showed a shorter induction time than propofol while maintaining comparable awakening and recovery times. Injection site pain was significantly lower in the remimazolam group than in the propofol group. The remimazolam group demonstrated a significantly higher quality of sedation and satisfaction scores than the propofol group, as evaluated by both endoscopists and patients.
Conclusions:
Remimazolam was superior to propofol in terms of safety and efficacy during EUS examinations. (Clinical trial registration number: KCT 0007643.).
Insights
Remimazolam offers a safer and more effective sedation option compared to propofol for endoscopic ultrasound (EUS) procedures. This novel agent resulted in fewer cardiorespiratory adverse events and improved patient and endoscopist satisfaction.
Area of Science:
- Gastroenterology
- Anesthesiology
- Pharmacology
Background:
- Propofol is a common sedative for GI endoscopy but causes cardiorespiratory suppression.
- Remimazolam is a new ultrashort-acting benzodiazepine with rapid onset and minimal cardiorespiratory effects.
Purpose of the Study:
- To compare the safety and efficacy of remimazolam versus propofol for sedation during endoscopic ultrasound (EUS) procedures.
- To evaluate cardiorespiratory adverse events, sedation quality, and patient/endoscopist satisfaction.
Main Methods:
- A multicenter randomized controlled study involving 400 patients undergoing EUS.
- Patients received either remimazolam or propofol.
- Primary endpoint: cardiorespiratory adverse events; Secondary endpoints: sedation/recovery times, pain, satisfaction.
Main Results:
- Remimazolam group had significantly fewer cardiorespiratory adverse events (8.5% vs. 16%, P=.022).
- Remimazolam showed a shorter induction time, comparable recovery, less injection site pain, and higher sedation quality and satisfaction scores.
- Trends toward less desaturation, respiratory depression, and hypotension were observed with remimazolam.
Conclusions:
- Remimazolam is superior to propofol for safety and efficacy in EUS sedation.
- Remimazolam presents a favorable alternative for procedural sedation, enhancing patient and provider experience.
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