Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: a Multicenter, Randomized, Single-blind, Non-inferio
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- #Sedation
- #Mechanical ventilation
- #Intensive Care Units
- Remimazolam tosylate was compared to propofol for sedation in postoperative mechanically ventilated ICU patients.
- The study was a multicenter, randomized, single-blind, non-inferiority, phase 3 trial (NCT06222294).
- Patients were randomized to receive either remimazolam tosylate or propofol, with target RASS of -2 to 1.
- Primary endpoint was sedation success, defined as maintaining target sedation for ≥70% of drug administration time without rescue sedation.
- Sedation success rates were 98.1% for remimazolam tosylate and 96.2% for propofol, meeting non-inferiority criteria.
- Mean percentage of time in RASS target range was similar between groups (95.1% vs 95.0%).
- Rescue sedation was rarely needed (0% for remimazolam tosylate vs 1% for propofol).
- Adverse events were mostly mild-moderate, with one severe event in the propofol group.
- Remimazolam tosylate demonstrated non-inferior efficacy and good tolerability compared to propofol.