Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial
Authors' conclusion
HSK3486 had a noninferior efficacy profile compared to propofol, exhibiting excellent tolerance.
Study context
- Population
- Patients undergoing nonemergency, noncardiothoracic, nonneurosurgical elective surgery128 completed
- Participants
- 129 patients
- Comparison
- HSK3486 vs propofol for GA induction and maintenance
- HSK3486n = 86
- Propofoln = 42reference
- Primary endpoint
- Success rate of anaesthetic maintenance (noninferiority: lower limit of 95% CI for between-group difference >−8%)
Methodological detailssingle-blinded, parallel-group, phase 3, non-inferiority, multicentre, 10 study centres, November 24, 2020 to January 25, 2021
- Single-blinded
- Parallel-group
- Phase 3
- Non-inferiority
- Multicentre
- 10 study centres, November 24, 2020 to January 25, 2021
Primary result
As reported in the abstract
95% CI −4.28% to 8.38%
Secondary outcomes
Successful induction, full alertness and spontaneous breathing recovery, time to leaving PACU, BIS changes
- No significant differences between groups (all P > 0.05)
Safety
Treatment-emergent adverse events (TEAEs)
P = 1.000
Drug-related TEAEs
P = 0.451
Original publication
Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. Published 19 January 2023. doi:10.
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