Comparison of the potency-ratio of ciprofol and propofol on sedative effects in painless hysteroscopy: a randomized double-blind dose-response study
摘要
Ciprofol has been investigated as a potential alternative to propofol for anesthesia because of its tendency to depress the respiratory and circulatory systems to a lesser extent and its association with less pain during injection. However, the relative potency of these two intravenous anesthetics has not been fully determined.
MethodsIn this randomized double-blind trial, 232 patients undergoing elective hysteroscopy were allocated to 8 groups (n = 29 each) receiving ciprofol (0.2, 0.3, 0.4, 0.5 mg/kg) or propofol (1.0, 1.5, 2.0, 2.5 mg/kg) as a single intravenous bolus. Dose-response relationships were analyzed using probit regression to estimate ED50(dose giving a 50% response) and ED95(dose giving a 95% response) and nonlinear regression (sigmoidal Emax model) to validate curve fitting. The primary endpoint was the success rates of anesthesia induction (MOAA/S ≤1 within 2 min).
ResultsData from 230 patients were available for analysis. The ED95 of ciprofol [0.53 mg/kg, 95% confidence interval (95% CI) 0.48–0.60] was non-overlapping with propofol (2.16 mg/kg, 95% CI 1.96–2.45), confirming the relative potency ratio for the two drugs 4.1 (95% CI 2.4–9.0). Ciprofol showed significantly lower incidences of injection pain (0% vs. 34.5%, P<0.01) and respiratory depression (27.6% vs. 55.2%, P<0.05) at doses around the ED50.
ConclusionCiprofol demonstrated a 4.1:1.0 potency ratio over propofol with superior safety in patients undergoing painless hysteroscopy, supporting its use as an alternative for brief procedures requiring rapid anesthesia induction and recovery.
Trial registrationClinicaltrials.gov identifier ChiCTR2200059853, May 13, 2022.