ICU sedation, delirium & recovery

Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial

AnesthesiologyPublished Randomised controlled trial

Primary resultResult — go to the resultDifference 1.9% 95% CI −3.3 to 7.8%

Authors' conclusion

Remimazolam tosylate demonstrated noninferior efficacy and good tolerability compared with propofol for short-term sedation in postoperative mechanically ventilated intensive care unit patients.

Study context

Population
Mechanically ventilated (99.1% postoperative) ICU patients requiring sedation for 6 h or longer, target Richmond Agitation-Sedation Scale (RASS) −2 to +1
Participants
211 participants
Comparison
Remimazolam tosylate vs propofol for sedation
  • Remimazolam tosylaten = 106
  • Propofoln = 105reference
Primary endpoint
Sedation success: maintaining target sedation range for 70% or more of drug administration time without rescue sedation
Methodological detailsmulticentre, single-blind, actively controlled, noninferiority, phase 3, Maximum treatment duration 24 h, March 12, 2024 to September 24, 2024
  • Multicentre
  • Single-blind
  • Actively controlled
  • Noninferiority
  • Phase 3
  • Maximum treatment duration 24 h
  • March 12, 2024 to September 24, 2024

Primary result

As reported in the abstract

Difference

1.9%

95% CI −3.3 to 7.8%

By group

Remimazolam tosylate vs Propofol
difference 1.9% (95% CI −3.3 to 7.8%)

Further findings

Rescue sedation

Treatment duration

Total dose

Mean

OutcomeRemimazolam tosylatePropofol
Percentage of time in RASS target range95.1% (SD 13.8%)95.0% (SD 12.9%)
Additional doses required0.03 (SD 0.17)0.18 (SD 0.77)
Terminal half-life of remimazolam tosylate
1.97 · mean · SD 1.62 · h

Safety

Adverse events

Adverse events

All mild-moderate, except one severe with propofol

Original publication

Efficacy and Safety of Remimazolam Tosylate versus Propofol for Sedation of Postoperative Mechanically Ventilated Patients in Intensive Care Units: A Multicenter, Randomized, Single-blind, Noninferiority, Phase 3 Trial. Anesthesiology. Published 19 March 2026. doi:10.1097/aln.0000000000006047

Composed by AI from the published abstract and checked against it. How Briefs are made →

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