Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-blind, Controlled, Phase 3 Noninferiority Trial
Primary result · Successful GA inductionResult — go to the resultDifference in success rate −0.57% 95% CI −5.4 to 4.2%Authors' conclusion
The study met its primary objective and endpoint, demonstrating noninferiority of HSK3486 compared with propofol in successful anesthetic induction. Substantially less injection-site pain was associated with HSK3486 than with propofol.
Study context
- Population
- Adults undergoing elective surgery with tracheal intubation251 analysed
- Participants
- 255 adults
- Comparison
- HSK3486 vs propofol for GA induction
- HSK3486n = 168
- Propofoln = 83reference
- Primary endpoint
- Successful anaesthesia induction (Modified Observer's Assessment of Alertness/Sedation score ≤1)
Methodological detailsmulticentre, double-blind, propofol-controlled, phase 3, non-inferiority, 2:1 randomisation
- Multicentre
- Double-blind
- Propofol-controlled
- Phase 3
- Non-inferiority
- 2:1 randomisation
Primary result
Successful GA induction
Difference in success rate
−0.57%
95% CI −5.4 to 4.2%
By group
HSK3486 vs Propofol
difference in success rate −0.57% (95% CI −5.4 to 4.2%)
As reported in the abstract
Secondary outcomes
Injection-site pain (NRS ≥1)
P < 0.0001
Composite endpoint (successful induction with desired anaesthetic depth, without substantial cardiac and respiratory events)
P = 0.8780
Safety
Study drug-related treatment-emergent adverse events (excluding injection-site pain)
Original publication
Comparison of the Efficacy of HSK3486 and Propofol for Induction of General Anesthesia in Adults: A Multicenter, Randomized, Double-blind, Controlled, Phase 3 Noninferiority Trial. Anesthesiology. Published 27 December 2023. doi:10.
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