Comparative study on the efficacy and safety of remimazolam versus midazolam for sedation during ERCP-related procedures in the elderly.
TL;DR
Remimazolam significantly shortened recovery time and reduced flumazenil use in elderly patients, which may reduce staff workload after ERCP; larger studies are needed to establish comparative safety.
Abstract
Objectives
Benzodiazepine agonists, commonly used sedatives for endoscopic retrograde cholangiopancreatography (ERCP) in Japan, may cause prolonged sedation, particularly in elderly patients. Although remimazolam, an ultra-short-acting benzodiazepine, has been approved for endoscopic sedation, its efficacy and safety in elderly patients remain unclear. We compared remimazolam and midazolam for sedation during ERCP-related procedures in patients aged ≥75 years.
Materials And Methods
This retrospective study included 208 patients aged ≥75 years: remimazolam group (R group, n = 106) and midazolam group (M group, n = 102). The primary outcome was the time to recovery (Aldrete score ≥9). Secondary outcomes included sedation success rate, number of doses, total doses administered, incidence of agitation requiring procedure interruption, procedure time, flumazenil use, and sedation-related adverse events.
Results
Recovery time was significantly shorter in the R group (median, 2 vs. 4 min, p <.01). Flumazenil use was significantly lower (4.7% vs. 28.4%, p <.01). The total number of doses administered was significantly higher in the R group (median, 3 vs. 2 times, p < .01). No significant differences were observed in sedation success rate, agitation requiring procedure interruption, procedure time, and sedation-related adverse events.
Conclusions
Remimazolam significantly shortened recovery time and reduced flumazenil use in elderly patients, which may reduce staff workload after ERCP; larger studies are needed to establish comparative safety.