Comparative study on the efficacy and safety of remimazolam versus midazolam for sedation during ERCP-related procedures in the elderly.

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.