Randomized controlled trial of remimazolam compared with placebo in Japanese patients undergoing colonoscopy: A phase III, investigator-initiated trial.

Abstract

We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopy. This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation achieved with remimazolam (initial dose: 3 mg; additional doses: 1 mg) or normal saline (placebo). The primary endpoint was the sedation success rate during colonoscopy, defined as successful sedation (modified observer's alertness/sedation [MOAA/S] score ≤4 prior to colonoscopy), the successful completion of the colonoscopy, and no more than five additional doses of remimazolam per 15 min during the procedure. The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p<0.01). The time from the end of the procedure to awakening was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 min (interquartile range: 0.0-10.0 min) in the remimazolam group and 0.0 min (interquartile range: 0.0-0.0 min) in the placebo group (p=0.02). No serious adverse events occurred. The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than the use of a placebo. This study was registered in the Japan Registry of Clinical Trials (registration number: jRCT2031200360).