Efficacy and Safety of Ciprofol for Sedation in Critically Ill Patients After Cardiac Surgery: A Single-Center, Prospective, Randomized Controlled Trial

Lulu Guo,1,* Min Hong,1,* Pingping Li,2,* Wenjing Du,1 Yongshuai Li,1 Jiaqiong Li2 1Department of Critical Care Medicine, Xuzhou Central Hospital, Xuzhou, Jiangsu, People’s Republic of China; 2Xuzhou Clinical College of Xuzhou Medical University, Xuzhou Medical University, Xuzhou, Jiangsu, People’s Republic of China*These authors contributed equally to this workCorrespondence: Jiaqiong Li, The Xuzhou Clinical College of Xuzhou Medical University, Xuzhou, Jiangsu, People’s Republic of China, Tel +86-18952170393, Email [email protected]: This study aimed to compare the efficacy and safety of ciprofol and propofol for sedation in critically ill patients after cardiac surgery.Patients and Methods: In this prospective, randomized controlled trial, 123 patients undergoing coronary artery bypass grafting (CABG) and/or valve surgery were randomly assigned to receive either ciprofol (Group C) or propofol (Group P) for postoperative sedation in the intensive care unit (ICU). Midazolam was administered if additional sedation was required, and remifentanil was used for analgesia. Sedation and analgesia were titrated to a target Richmond Agitation-Sedation Scale (RASS) score of − 2 to +1 and a Critical-Care Pain Observation Tool (CPOT) score < 3. The primary endpoint was the mean sedation compliance rate, defined as the percentage of RASS scores within the target range during the initial 24 hours. Secondary endpoints included safety events, extubation time, length of ICU stay, mortality, delirium incidence, and postoperative recovery.Results: In the per-protocol (PP) population, sedation compliance was 92.77% (Group C) and 94.30% (Group P). Ciprofol showed non-inferior sedation to propofol in cardiac surgery patients; the lower limit of the one-sided 95% confidence interval (CI) for rate difference (RD) exceeded the − 8% non-inferiority margin in both PP and intention-to-treat (ITT) populations. The incidence of hypotension was numerically lower in Group C (31.3% vs 40.7%; P = 0.276), with no significant differences in other safety or secondary outcomes (all P > 0.05).Conclusion: In summary, ciprofol provides non-inferior sedation efficacy and a comparable safety profile to propofol in critically ill patients following cardiac surgery. A numerical trend toward lower hypotension incidence was observed with ciprofol, which warrants further validation in future studies.Keywords: ciprofol, propofol, cardiac surgery, intensive care, sedation, safety