Efficacy and safety of ciprofol (HSK3486) for procedural sedation and anesthesia induction in surgical patients: A systematic review and meta-analysis.

Background: Ciprofol (HSK3486) is a novel gamma-aminobutyric acid type A (GABAA) receptor agonist that has attracted wide attention because of its lower injection pain and fewer adverse events. We summarized all available evidence and analyzed the efficacy and safety of ciprofol during procedural sedation and anesthesia induction.

Methods: An electronic search of PubMed, Embase, Cochrane Library, Web of Science, Google Scholar, Science Direct, the Chinese National Knowledge Infrastructure, Wan Fang Data, and the VIP Chinese Journal Service platform was conducted from inception of databases to March 1, 2023. Risk ratio (RR) and mean difference (MD) with 95 % confidence interval (CI) were used separately for binary categorical and continuous variables. We performed trial sequential analysis and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology to judge the certainty of evidence.

Results: Fifteen randomized controlled trials with 2441 patients were included in this study. Ciprofol showed similar advantages to propofol in terms of induction success rate (RR = 1, 95 % CI = 0.99, 1.01, moderate certainty) and induction time (MD = 3.31, 95 % CI = -0.34, 6.95, low certainty), but did not increase the incidence of adverse events (RR = 0.88, 95 % CI = 0.78, 1.00, very low certainty), such as bradycardia (RR = 0.96, 95 % CI = 0.77, 1.21, high certainty), hypoxia (RR = 0.79, 95 % CI = 0.46, 1.37, p = 0.40, moderate certainty) and other adverse events. Although it may be associated with a longer time to be fully alert (MD = 1.22, 95 % CI = 0.32, 2.12, very low certainty), ciprofol significantly reduced injection pain (RR = 0.15, 95 % CI 0.09, 0.24, low certainty) and may have reduced the incidence of hypotension (RR = 0.77, 95 % CI = 0.63, 0.94, low certainty) and respiratory depression (RR = 0.29, 95 % CI = 0.15, 0.56, moderate certainty).

Conclusion: Ciprofol and propofol had similar effects on most outcomes. While the time to full alertness may be prolonged, injection pain was significantly reduced, and hypotension and respiratory depression may be reduced compared with propofol. We believe that ciprofol is an effective alternative to intravenous anesthetic agents.