Efficacy and safety of ciprofol for general anesthesia induction in female patients with frailty: a prospective randomized controlled trial.

Abstract

Background: Ciprofol, a recently developed anesthetic agent, is not inferior to propofol in terms of efficacy and safety. However, most previous clinical experience with ciprofol was based on a robust population. This study aimed to investigate the efficacy and safety of ciprofol for anesthesia induction in female patients with frailty.

Methods: This prospective randomized controlled trial included patients with frailty undergoing elective general anesthesia for gynecological surgery. Frailty was assessed using the modified frailty index. The patients were randomly administered propofol (2 mg/kg) or ciprofol (0.5 mg/kg) during anesthesia induction. The depth of anaesthesia was continually monitored by the bispectral index. The primary outcome was the lowest systolic blood pressure (SBP) during anesthesia induction. Secondary outcomes included the incidence of general anesthesia induction failure and adverse events.

Results: Among the 69 enrolled patients with frailty, 67 were included in the final analysis. The success rate of anesthesia induction was 100% in both groups. The lowest SBP was significantly higher in the ciprofol group than in the propofol group (103 [96-110] vs. 90 [85-98] mmHg, respectively; P < 0.001), suggesting that the former caused less inhibition of hemodynamics during anesthesia induction in patients with frailty. The incidence of injection pain was lower in the ciprofol group than in the propofol group (3 [8.8%] vs. 11 patients [33.3%], respectively; P = 0.014).

Conclusions: The results of this study suggest that the efficacy of ciprofol for inducing general anesthesia in patients with frailty is comparable to that of propofol, with more stable hemodynamics.

Trial registration: The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (Clinical trial number: ChiCTR2300075271; https://www.chictr.org.cn/showproj.html?proj=205160 , principal investigator's name: Zifeng Xu, date of registration: 31/08/2023).