Safety and efficacy of remimazolam in high risk colonoscopy: A randomized trial

• Published in: Digestive and liver disease 2021-01, Vol.53 (1), p.94-101
• Main Authors: Rex, Douglas K., Bhandari, Raj, Lorch, Daniel G., Meyers, Michael, Schippers, Frank, Bernstein, David
• Format: Article
• Language: English
• Subjects: Aged; Benzodiazepines - administration & dosage; Benzodiazepines - adverse effects; Colonoscopy; Colonoscopy - methods; Conscious Sedation - methods; Double-Blind Method; High risk colonoscopy; Humans; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - adverse effects; Middle Aged; Prospective Studies; Remimazolam; Sedation
• ISSN: 1590-8658; 1878-3562
• DOI: 10.1016/j.dld.2020.10.039

Procedural sedation of ASA III/IV patients has increased risk. Remimazolam (an ultra-short-acting benzodiazepine) has proven safe and efficient for outpatient colonoscopy sedation. A double-blind, randomized, multi-center, parallel group trial was performed, comparing remimazolam to placebo with an additional open-label arm for midazolam in procedural sedation of 79 ASA III/IV patients undergoing colonoscopy. This was the third of 3 Phase III trials for remimazolam in the procedural sedation program. The primary end point was the safety of remimazolam. Of 79 patients randomized at 3 US sites, 77 underwent sedation and colonoscopy (31 received remimazolam, 16 placebo and 30 midazolam). Incidence and frequency of treatment emergent adverse events (TEAEs) were comparable in all three treatment arms, and independent of ASA status. One TEAE leading to discontinuation and one serious TEAE were reported; both in the open label midazolam arm. The efficacy endpoint was achieved for remimazolam, placebo, and midazolam in 87.1%, 0%, and 13.3% of patients (p