United European gastroenterology journal · 2025
Remimazolam Preserves Oxygen Reserve and Improves Sedation Safety Compared to Propofol in Endoscopic Retrograde Cholangiopancreatography.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Kim Jee Hoon, Lee Kyuho, Lee Sung Jin, Leem Galam, Lee Hee Seung, Park Jeong Youp, Bang Seungmin, Park Seung Woo, Kim Namo, Chung Moon Jae
Аннотация
BACKGROUND: Remimazolam is a short-acting benzodiazepine with less cardiorespiratory depression compared with propofol. The Oxygen Reserve Index (ORi) reflects oxygenation status in the mild hyperoxic range and can detect subtle respiratory depression induced by sedatives.
OBJECTIVE: We compared remimazolam and propofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and assessed the ORi to evaluate the impact of these sedatives on oxygen reserve.
METHODS: Patients scheduled for ERCP were enrolled and randomly assigned to either the remimazolam or the propofol group. They received 0.1 mg kg-1 remimazolam or 1.0 mg kg-1 propofol, with bolus injections of either 2 mg remimazolam or 20 mg propofol added as required, according to the group allocation. The primary outcome was the incidence of oxygen reserve depletion, defined as an ORi reduction to 0.00.
RESULTS: Among the 102 patients, oxygen reserve depletion was more frequent in the propofol group (70.6% vs. 41.2%, odds ratio 0.29, 95% confidence interval 0.13-0.66, p = 0.003). The time from sedative injection to endoscope insertion, length of stay in the recovery room, and overall procedure time were comparable between the groups. Patients in the remimazolam group reported a lower incidence of procedural recall, fewer complaints of inadequate sedation, and higher satisfaction scores than those in the propofol group.
CONCLUSIONS: Remimazolam effectively preserved the oxygen reserve compared with propofol, lowering the risk of hypoxia during sedation. Remimazolam was also associated with more favorable recovery profiles for patients undergoing ERCP, making it a safe and preferred sedative for this procedure.
TRAIL REGISTRATION: Clinicaltrials.gov: NCT06359834.
OBJECTIVE: We compared remimazolam and propofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) and assessed the ORi to evaluate the impact of these sedatives on oxygen reserve.
METHODS: Patients scheduled for ERCP were enrolled and randomly assigned to either the remimazolam or the propofol group. They received 0.1 mg kg-1 remimazolam or 1.0 mg kg-1 propofol, with bolus injections of either 2 mg remimazolam or 20 mg propofol added as required, according to the group allocation. The primary outcome was the incidence of oxygen reserve depletion, defined as an ORi reduction to 0.00.
RESULTS: Among the 102 patients, oxygen reserve depletion was more frequent in the propofol group (70.6% vs. 41.2%, odds ratio 0.29, 95% confidence interval 0.13-0.66, p = 0.003). The time from sedative injection to endoscope insertion, length of stay in the recovery room, and overall procedure time were comparable between the groups. Patients in the remimazolam group reported a lower incidence of procedural recall, fewer complaints of inadequate sedation, and higher satisfaction scores than those in the propofol group.
CONCLUSIONS: Remimazolam effectively preserved the oxygen reserve compared with propofol, lowering the risk of hypoxia during sedation. Remimazolam was also associated with more favorable recovery profiles for patients undergoing ERCP, making it a safe and preferred sedative for this procedure.
TRAIL REGISTRATION: Clinicaltrials.gov: NCT06359834.