Background: Remimazolam is an ultrashort-acting benzodiazepine that is potentially a practical option for procedural sedation in colonoscopy.
Objective: To test the hypothesis that remimazolam could provide a noninferior discharge time to propofol for ambulatory colonoscopy.
Design: A prospective, randomised, double-blind, noninferiority clinical trial.
Setting: Ambulatory endoscopy centre.
Patients: A total of 132 adult participants undergoing ambulatory colonoscopy were enrolled.
Interventions: Participants were randomly assigned in a 1 : 1 ratio to receive propofol or remimazolam for sedation.
Main outcome measures: The primary outcome was discharge time after a colonoscopy, assessed using the Modified Postanaesthetic Discharge Scoring System scale. Secondary outcomes included induction time, emergence time, the extent of recovery upon arrival in the postanaethesia care unit, fatigue, endoscopist and patient satisfaction and adverse events.
Results: The median discharge time was 24 min in the remimazolam group versus 21 min in the propofol group, with a difference of 2 min [95% confidence interval (CI), 0 to 4 min], meeting the criteria for noninferiority. Injection pain occurred in 11 of 66 (17%) participants receiving remimazolam versus 32 of 66 (49%) participants receiving propofol ( P < 0.001); hypotension occurrence was 20% versus 47%, ( P < 0.001), respectively, and bradycardia 6% versus 20%, ( P = 0.019), respectively. Compared with propofol, the patient satisfaction score was higher in the remimazolam group ( P < 0.001).
Conclusion: For sedation in ambulatory colonoscopy, compared with propofol, remimazolam provides a noninferior discharge time. Furthermore, remimazolam is associated with less injection pain, lower risks of hypotension and bradycardia, and improved patient satisfaction.
Trial registration: Chinese Clinical Trial Registry, identifier: ChiCTR2100048678.
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