Remimazolam versus propofol for postoperative ICU sedation in mechanically ventilated cancer patients: a noninferiority randomized clinical trial

Objective: This study aimed to compare the efficacy and safety of the novel ultra-short-acting benzodiazepine, remimazolam, versus propofol for short-term sedation in postoperative cancer patients during mechanical ventilation in the ICU. Methods: This single-center, randomized noninferiority clinical trial was conducted from February 1st to 31 August 2024. Adult postoperative cancer patients requiring mechanical ventilation in the ICU were randomized to receive either remimazolam or propofol. The primary outcomes were the time to achieve target sedation (Richmond Agitation-Sedation Scale, RASS, -2 to 0) and the percentage of time within the target range without rescue sedation. Results: A total of 80 patients were enrolled and randomly assigned to the remimazolam group (n = 40) or the propofol group (n = 40). The time to achieve target sedation was comparable between the remimazolam and propofol groups [median 3.0 (IQR 2.0-4.0) vs. 3.0 (IQR 2.0-4.5) minutes, P = 0.590]. The median percentage of time within the target sedation range was also similar (80.0% vs. 73.2%, P = 0.546). However, remimazolam demonstrated a superior safety profile, with significantly lower incidences of hypotension (15.0% vs. 42.5%, P = 0.007) and respiratory depression (5.0% vs. 20.0%, P = 0.043). No significant differences were observed in secondary outcomes, including duration of mechanical ventilation, ICU length of stay, mortality, or costs. Conclusion: In mechanically ventilated, postoperative cancer patients, remimazolam provides non-inferior sedation efficacy compared to propofol, but with a significantly more favorable safety profile, particularly regarding hemodynamic and respiratory stability. These findings position Remimazolam as a promising and safer alternative for sedation in this vulnerable population.