Objectives: In gastroenterology, sedation demand is increasing, although elderly patients are more prone to experiencing adverse events. Remimazolam, a novel ultra-short-acting benzodiazepine, may reduce recovery time after endoscopic procedures.
Methods: This study was a secondary analysis of the investigator-initiated trial, which investigated the efficacy and safety of remimazolam in gastrointestinal endoscopy (REM-IICT JP01). Remimazolam sedation was administered during upper gastrointestinal endoscopy. Patients were divided into two groups: 45 non-elderly and 11 elderly patients (aged ≥65 years). The primary outcome was sedation success. Secondary outcomes included the dose required for sedation, time to awakening, time to regain the ability to walk, and occurrence of adverse events.
Results: Endoscopic sedation was successful in 95.6% of the non-elderly group and 100% of the elderly group. The total dose of remimazolam was significantly higher in the non-elderly group (4.0 [3.0-8.0] mg) than in the elderly group (3.0 [2.0-3.0] mg; p < 0.01). The time to awakening was 0.0 (0.0-10.0) min in the non-elderly group compared to 0.0 (0.0-30.0) min (p = 0.98) in the elderly group. The time to regain the ability to walk was significantly longer in the elderly group (5.0 [0.0-60.0] min) than in the non-elderly group (5.0 [0.0-30.0] min; p = 0.03). During the procedure, adverse events included hypotension in two cases (4.4%) in the non-elderly group and hypoxemia in one case (9.0%) in the elderly group.
Conclusions: Upper gastrointestinal endoscopy with remimazolam was effective and safe, regardless of age.
Keywords: benzodiazepine; elderly; gastrointestinal endoscopy; safety; sedative.
© 2025 The Author(s). DEN Open published by John Wiley & Sons Australia, Ltd on behalf of Japan Gastroenterological Endoscopy Society.