Short-term light sedation with remimazolam besylate versus propofol in the ICU (SHOSREB): a multicentre, randomized, single-blind, controlled trial.

Abstract

To explore the efficacy and safety of remimazolam besylate in short-term sedation in the ICU in comparison with propofol. A multicenter, randomized, single-blind, non-inferiority trial was conducted in mechanically ventilated patients, who needed light sedation, defined as Richmond Agitation-Sedation Scale (RASS) scores between -2 and + 1. The primary outcome was successful sedation, which was defined as no rescue sedative administered during the study drug infusion period while maintaining RASS scores between -2 and + 1 for at least 70% of the total infusion time. A total of 164 participants were included and randomized equally into the remimazolam group and the propofol group. Remimazolam was continuously infused for 10.5 [8.1-14.7] h and propofol for 11.0 [7.0-14.3] h (p = 0.534). The median average maintaining dose of remimazolam and propofol was 0.20 [0.19-0.30] mg·kg⁻¹·h⁻¹ and 0.61 [0.30-1.17] mg·kg⁻¹·h⁻¹, respectively. The percentage of participants successfully sedated in both groups was 97.5% (p = 0.497) with a difference of 0 (95% confidence interval (CI) -6.5% to 6.4%), above the predefined non-inferiority margin of -8%. There was no significant difference in the mean percentage of time with target RASS scores between the remimazolam group (88.6%; 95% CI: 84.2%-92.9%) and the propofol group (89.4%; 95% CI: 85.0%-93.8%) (p = 0.543). Remimazolam besylate could be non-inferior to propofol for achieving successful short-term light sedation in the ICU. ClinicalTrials.gov identifier: NCT05782894 on Feb 18th, 2023.