Efficacy and safety of remimazolam sedation for gastrointestinal endoscopy in elderly versus non-elderly patients

Background/aims This study aimed to evaluate the efficacy, recovery profile, and safety of remimazolam sedation during gastrointestinal (GI) endoscopy in elderly and non-elderly patients. Methods This post hoc secondary analysis used data from a multicenter randomized controlled trial of remimazolam vs. midazolam for sedated GI endoscopy in Japan (jRCTs071240062). Patients receiving remimazolam were divided into elderly (≥65 years, n=19) and non-elderly (n=20) groups. Outcomes included sedation success, sedative dose, time to awakening, time to ambulation, and adverse events. Results Sedation was successful in 100% of patients in both groups. ASA-PS class I was less common in the elderly group (26.3% vs. 65.0%, p=0.025), whereas the upper/lower GI endoscopy ratio did not differ (12/7 vs. 8/12, p=0.205). Total remimazolam dose was significantly lower in the elderly group (3.7 ± 0.9 vs. 5.7 ± 1.6 mg, p<0.001). More elderly patients were sedated with the initial dose alone (52.6% vs. 5.0%, p=0.001). Time to awakening (1.9 ± 3.5 vs. 0.8 ± 1.8 min, p=0.205) and ambulation (3.9 ± 3.7 vs. 2.0 ± 2.5 min, p=0.077) did not differ significantly. Adverse events were observed only in the elderly group (4/19 [21.1%] vs. 0/20, p=0.047), including hypoxemia (n=2), hypertension (n=1), and hypotension (n=1), all of which were mild and resolved with minimal intervention. Conclusion Remimazolam provided effective sedation for GI endoscopy, and elderly patients received a lower total dose under the study protocol. Although these adverse events were mild and resolved with minimal intervention, their occurrence in elderly patients warrants careful monitoring. These exploratory findings warrant confirmation in adequately powered prospective studies.