Remimazolam Besylate Versus Propofol for Procedural Sedation in Patients Undergoing Electrical Cardioversion: A Prospective, Noninferiority Cohort Study.

OBJECTIVE

Remimazolam besylate is a novel, short-acting benzodiazepine with a more favorable hemodynamic and respiratory profile than traditional anesthetics and may be suitable for procedural sedation. The objective of this study was to assess the safety, feasibility, and clinical advantages of remimazolam compared to propofol for procedural sedation during electrical cardioversion.

DESIGN

A prospective observational study.

SETTING

The Electrophysiology Department of a tertiary referral center university hospital.

PARTICIPANTS

Sixty consecutive adult patients undergoing procedural sedation during electrical cardioversion for atrial fibrillation.

INTERVENTION: Patients receiving remimazolam (n = 30) were compared to those receiving propofol (n = 30) for procedural sedation.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome of time to loss of consciousness was evaluated in a prespecified noninferiority analysis. Other outcomes included adequacy of sedation, the time course of hemodynamics, time to recovery of consciousness, and adverse drug events. The achievement of satisfactory sedation was similar between the remimazolam (n = 29, 97%) and propofol (n = 30, 100%) groups. The mean difference in time to loss of consciousness between the groups was within the margin of noninferiority (0.41 minutes; 95% confidence interval, -0.38 to 1.20 minutes). In the linear mixed-effects model, remimazolam produced significantly more favorable blood pressure indexes but similar oxygen saturations compared to propofol over the course of the procedure. Three patients in the propofol group required rescue ventilation.

CONCLUSIONS

Remimazolam was associated with similar sedation adequacy but more favorable hemodynamics over time compared to propofol when used for procedural sedation in adults undergoing electrical cardioversion for atrial arrhythmias.