Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation: a single-center, double-blind, randomized, controlled clinical trial

Abstract

Ciprofol, a novel γ-aminobutyric acid receptor agonist, outperforms propofol with minimal cardiovascular effects, higher potency, reduced injection pain, and a broader safety margin. Despite these advantages, ciprofol's clinical research is still emerging. This study compares the median effective dose (ED50) and adverse reactions of ciprofol and propofol, in conjunction with sufentanil, for suppressing cardiovascular responses during tracheal intubation.A total of fifty-three adult patients who required general anesthesia for tracheal intubation were enrolled in this study. The patients were randomly assigned to either the ciprofol group (group C) or the propofol group (group P) using a random number table. Tracheal intubation was performed using a standardized laryngoscope and endotracheal tube. The Dixon's up-and-down method was employed to determine the ED50 and 95% effective dose (ED95) of ciprofol and propofol in inhibiting cardiovascular responses during tracheal intubation. Based on the pilot study, the initial dose of ciprofol was set at 0.35 mg/kg (with a dose increment of 0.01 mg/kg) and propofol was set at 2.0 mg/kg (with a dose increment of 0.1 mg/kg). Dose-response curves were generated using probit analysis to establish the ED50 and ED95 required to inhibit cardiovascular responses during tracheal intubation. Adverse events following drug administration were closely monitored.A total of 54 participants were included in the study, with 24 in group C (one participant excluded due to repeated intubation) and 30 in group P. Probit analysis revealed that the ED50 and ED95 of ciprofol for inhibiting cardiovascular responses to tracheal intubation were 0.326 mg/kg (95% CI 0.304-0.337 mg/kg) and 0.349 mg/kg (95% CI 0.337-0.470 mg/kg), and for propofol, 1.541 mg/kg (95% CI 1.481-1.599 mg/kg) and 1.656 mg/kg (95% CI 1.599-1.943 mg/kg). Notably, group C demonstrated more stable hemodynamics during induction and showed a significantly lower incidence of injection pain compared to group P. Ciprofol demonstrated more stable hemodynamics and a lower incidence of adverse events during induction. Ciprofol may potentially be used as a substitute for propofol in a wider range of scenarios. Clinical Trial Registration: hppts://ClinicalTrials.gov; Identifier: NCT06095570(23/10/2023).