HSK3486-304
Trial question
Is ciprofol noninferior to propofol for induction of general anesthesia in adults?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
70.0% female
30.0% male
N = 251
251 patients (176 female, 75 male).
Inclusion criteria: adult patients undergoing elective surgery with tracheal intubation.
Key exclusion criteria: history of adverse reactions to sedation or general anesthesia; allergies to opioids or their antidotes or propofol and its constituents; use of medications known to interact synergistically with propofol or ciprofol; cardiovascular or respiratory disorders; previous failure of a difficult airway for tracheal intubation.
Interventions
N=168 ciprofol (0.4 mg/kg IV slow injection, followed by a 0.2 mg/kg top-up dose if needed).
N=83 propofol (2.0 mg/kg IV slow injection, followed by a 1.0 mg/kg top-up dose if needed).
Primary outcome
Successful anesthesia induction
97%
97.6%
97.6 %
73.2 %
48.8 %
24.4 %
0.0 %
Ciprofol
Propofol
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in successful anesthesia induction (97% vs. 97.6%; ARD -0.57, 95% CI -5.4 to 4.2).
Secondary outcomes
Significant decrease in mild injection site pain (18% vs. 77.1%; ARD -59.14, 95% CI -69.9 to -48.4).
Significant decrease in severe injection site pain (6% vs. 61.4%; ARD -55.46, 95% CI -66.5 to -44.4).
No significant difference in the proportion of patients successfully induced while maintaining desired depth of anesthesia without substantial cardiac and respiratory events (48.2% vs. 50.6%; ARD -2.4, 95% CI -30.82 to 26.02).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In adult patients undergoing elective surgery with tracheal intubation, ciprofol was noninferior to propofol with respect to successful anesthesia induction.
Reference
Tong J Gan, Todd Bertoch, Ashraf S Habib et al. 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. 2024 Apr 1;140(4):690-700.
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