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Clinical Trial
. 2025 Aug 29:19:7541-7552.
doi: 10.2147/DDDT.S536225. eCollection 2025.

Effect of Ciprofol on Postoperative Cognitive Function in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Jun Lu #  1 , Yewei Shi #  1 , Xin Lan  1 , Guangling Tang  1 , Yi Shao  1 , Chao Chen  1 , Xinglong Xiong  1 , Dongxu Chen  2   3 , Jing Shi  1
Affiliations
Clinical Trial

Effect of Ciprofol on Postoperative Cognitive Function in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Jun Lu et al. Drug Des Devel Ther. .

Abstract

Purpose: To investigate the effects of ciprofol on postoperative cognitive function in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Patients and methods: A total of 138 patients who underwent cardiac surgery with cardiopulmonary bypass were included in this prospective, randomized, controlled study. Patients were randomized into two groups: the Ciprofol group (Group C) and the Propofol group (Group P). During anesthesia induction and maintenance, the patients in Group C received ciprofol, whereas those in Group P received propofol. The primary outcome measure was the incidence of postoperative delirium (POD), which was assessed twice daily for 7 days after surgery via either the Confusion Assessment Method (CAM) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Statistical analyses included chi-square tests for categorical outcomes and relative risk calculations for POD. Additionally, delirium subtypes were recorded. The incidence of postoperative cognitive dysfunction (POCD) was evaluated at 1 and 3 months after surgery using the Telephone Montreal Cognitive Assessment (T-MoCA). Furthermore, the occurrence of postinduction adverse events, including hypotension, bradycardia, and tachycardia, as well as the incidence of postoperative complications, were also documented.

Results: POD occurred in 19/64 (29.69%) patients in the Ciprofol group and 34/65 (52.31%) patients in the Propofol group (RR = 0.57; 95% confidence interval = 0.37 to 0.88; p = 0.009). There was no significant difference in the incidence of POCD at 1 month (22.03% vs 26.62%, p = 0.547) or 3 months (16.25% vs 16.00%; p = 0.771) after surgery between the two groups.

Conclusion: Ciprofol was found to decrease the incidence of POD in patients who underwent cardiac surgery with cardiopulmonary bypass. Nevertheless, no significant effect of this intervention on the incidence of POCD was demonstrated at either 1 or 3 months after surgery. A reduction in the incidence of delirium may be associated with improved postoperative recovery, shortened hospital stays, and a decrease in long-term cognitive impairments.

Registration: The study had been registered in the Chinese Clinical Trials Registry (www.chictr.org.cn; Trial Identifier: ChiCTR2200061712).

Keywords: cardiac surgery; cardiopulmonary bypass; ciprofol; cognitive function; delirium.

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Conflict of interest statement

Jing Shi is the first correspondence author for this study. The authors report no conflicts of interest in this work. An unauthorized version of the Chinese MMSE was used by the study team without permission, however this has now been rectified with PAR. The MMSE is a copyrighted instrument and may not be used or reproduced in whole or in part, in any form or language, or by any means without written permission of PAR (www.parinc.com).

Figures

Figure 1
Figure 1
Flow chart of patients enrollment.
Figure 2
Figure 2
Cumulative hazard of postoperative delirium.
Figure 3
Figure 3
Intraoperative vital signs.
See this image and copyright information in PMC

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