Safety and Efficacy of Remimazolam for Colonoscopy Sedation

Remimazolam is an ultrashort-acting benzodiazepine proposed for sedation in gastrointestinal endoscopy. To assess its safety and efficacy, researchers conducted an industry-funded, phase III, FDA-required trial, randomizing approximately 300 patients undergoing colonoscopy to receive remimazolam, 60 to receive placebo (fentanyl alone), and 100 to receive midazolam in an open-label arm.

All patients initially received 50 to 75 mcg of fentanyl, then either 5 mg of remimazolam or placebo. Top-up doses of remimazolam (2.5 mg) or placebo were given to achieve adequate sedation (with ≥2 minutes between doses). Additional doses of fentanyl were allowed up to 200 mcg total. Midazolam was used as rescue medication. The primary endpoint was a composit…