Simultaneous Plenary Session 1: Colon / Stomach
45 - Remimazolam Is a Safe and Effective Agent for Sedation in Outpatient Colonoscopy: Results of a Phase 3, Multicenter, Randomized, Placebo Controlled Trial
Tuesday, October 18
3:35 PM - 3:45 PM
Room: Venetian Ballroom E
Presenting Author(s):
Douglas K. Rex, MD, MACG
Distinguished Professor of Medicine, Indiana University Hospital, Indianapolis, IN
Brooks Cash, MD, FACG - Paion Inc.:Consultant
David Bernstein MD, FACG - Paion Inc.:Consultant
Introduction: Remimazolam (RM) is a new, ultra short acting benzodiazepine with potential benefits for use in procedural sedation.
Methods: A prospective, randomized, double-blind, placebo controlled study, comparing remimazolam and placebo with an open-label midazolam (MDZ) arm at 13 US sites for colonoscopy in ASA I-III patients. Sedation was given under supervision of an endoscopist. The primary endpoint was procedural success defined as completion of colonoscopy plus no requirement for an alternative sedative plus no more than a defined number of additional doses of sedative.
Results: 461 patients were randomized, mean age 54.5 yrs, 52.5% female, and comparable demographics between groups. Procedural success was significantly better in the RM group compared to placebo and MDZ. (Table 1) Mean times to fully alert and discharge were lower in the RM group than the other 2 groups. Physician assessment of readiness for discharge after 30 min was better for RM on 100mm visual analogue scale (62 vs 8) compared to placebo. There were no treatment-emergent serious adverse events. Nadirs in heart rate, respiratory rate and blood pressure were lower with MDZ than RM. Overall adverse events were 16% lower with RM compared to MDZ (p=.0006), treatment emergent AE’s were 17.5% lower in the RM group (p=.0003). Hypotension was less with RM. Patient satisfaction was similar in all arms.
Discussion: Remimazolam is a safe and effective for conscious sedation in colonoscopy, with significant gains in recovery time and restoration of neuropsychiatric function when compared to MDZ and placebo.