Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial
Authors' conclusion
This trial established the noninferior sedation success rate of remimazolam (0.2 mg/kg but not 0.15 mg/kg) compared with propofol (1.5 mg/kg), with a superior safety profile.
Study context
- Population
- Patients scheduled for gastroscopy, five centres, March 2021–July 2022
- Participants
- 1,883 patients · 5 centres
- Comparison
- Remimazolam 0.15 or 0.2 mg/kg vs propofol 1.5 mg/kg
- Primary endpoint
- Sedation success rate
Methodological detailsmulticentre, single-blind, parallel-controlled, non-inferiority
- Multicentre
- Single-blind
- Parallel-controlled
- Non-inferiority
Primary result
As reported in the abstract
Each group vs 1.5 mg/kg propofolRisk difference (97.5% CI)
0.2 mg/kg remimazolamnoninferiority criteria met
−0.64%(−2.2 to 0.7%)
0.15 mg/kg remimazolaminferiority demonstrated
−10.8%(−14.0% to −8.0%)
Non-inferiority margin 5 as printed, not drawn
Safety
Overall AEs; bradycardia, hypotension, subclinical respiratory depression, hypoxia
- Overall AE rate lower with remimazolam than propofol
- Bradycardia, hypotension, subclinical respiratory depression and hypoxia significantly lower in remimazolam groups vs propofol
Original publication
Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial. Anesthesiology. Published 1 December 2023. doi:10.
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