The effects of ciprofol on haemodynamics under general anaesthesia during thoracoscopic surgery: a randomised, double-blind, controlled trial

Abstract

Background: Propofol, a widely administered sedative, is associated with potential hemodynamic instability during anaesthesia. Ciprofol introduces a cyclopropyl group to the chemical structure of propofol, forming an R-shaped hand structure and is characterised by rapid induction, rapid recovery, good controllability and a high degree of clinical safety.

Methods: This prospective randomised, double-blind, controlled clinical trial aimed to assess the effects of ciprofol on haemodynamics and its safety and efficacy under general anaesthesia during thoracoscopic surgery. A total of 60 patients undergoing thoracoscopic surgery at First Affiliated Hospital of Guangxi Medical University between March 2023 and June 2023 were enrolled and 1:1 randomly assigned to receive anaesthesia with ciprofol or propofol. The primary outcomes were the incidences of cardiovascular events including hypertension, hypotension, bradycardia and tachycardia, the fluctuations in haemodynamic parameters. The secondary outcomes were injection pain, the bispectral index (BIS), the time of loss of consciousness and the time of disappearance of the eyelash reflex. For baseline characteristics, continuous variables were compared using Student's t-tests or Wilcoxon rank-sum tests, while categorical variables were analysed using the Chi-square test. For fluctuations in haemodynamic parameters, repeated measures analysis of variance (ANOVA) was performed.

Results: The Chi-square tests revealed no difference in the incidence of cardiovascular events (hypertension, hypotension, bradycardia and tachycardia) between ciprofol group and propofol group during both anaesthesia induction and maintenance. The ANOVA test showed that the decrease of mean arterial pressure (MAP) at T1 was gentler in the ciprofol group compared to the propofol group (p = 0.02). The difference between the heart rate at T5 and baseline (▲HR) in the ciprofol group was significantly lower than in the propofol group (p = 0.01). The ciprofol group had a lower incidence of injection pain in comparison with the propofol group (10.0% versus 23.3%, p = 0.028). The time of disappearance of the eyelash reflex was less in the ciprofol group than in the propofol group (p = 0.004).

Conclusions: Ciprofol is a safe and effective anaesthetic that may be used as a substitute for propofol in the induction and maintenance of anaesthesia in thoracoscopic surgery.

Trial registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2300069650) on March 22, 2023.

Keywords: Cardiovascular events; Ciprofol; General anaesthesia; Haemodynamic; Propofol; Thoracoscopic surgery.

Fig. 1

Consort flow diagram of patients C, ciprofol; P, propofol

Fig. 2

Fluctuations in blood pressure during anaesthesia C, ciprofol; P, propofol; MAP, mean arterial pressure; ▲MAP, difference between mean arterial pressure and baseline

Fig. 3

Fluctuations in heart rate during anaesthesia C, ciprofol; P, propofol; HR, heart rate; ▲HR, difference between heart rate and baseline

Fig. 4

BIS, the time of loss of consciousness and eyelash reflex C, ciprofol; P, propofol; BIS, bispectral index