ORIGINAL RESEARCH article
Front. Med.
Sec. Intensive Care Medicine and Anesthesiology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1590922
Effectiveness and safety of ciprofol for induction and maintenance of general anesthesia in urological surgery: a prospective, non-inferiority cohort study
Provisionally accepted
- 1Department of Radiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- 2Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hebei Province, China
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Introduction: Ciprofol is a newly developed intravenous agent, with limited clinical data available to date. The aim of this study was to evaluate the effectiveness and safety of ciprofol for general anesthesia in patients undergoing urological surgery. Methods: This study consecutively enrolled 172 urological patients aged ≥ 18 years who received general anesthesia. Eligible 166 patients were assigned to two groups: ciprofol (n = 85; induction 0.3– 0.4 mg·kg-1; maintenance, 1.0–1.5 mg·kg-1·h-1) or propofol (n = 81; induction, 1.5–2.0 mg·kg-1; maintenance, 4–8 mg·kg-1·h-1). The primary effectiveness endpoint was the between-group difference in anesthesia success rate. The secondary effectiveness endpoints were the normal rate of Bispectral Index (BIS), time to adequate sedation, time to loss of eyelash reflex, diachronic changes in the BIS, mean arterial pressure (MAP), heart rate, recovery time, and extubation time. Adverse events were recorded to evaluate the safety profiles of ciprofol. Results: The anesthesia success rate was 100% in both groups. The lower limit of the 95% confidence interval for the rate difference exceeded the prespecified non-inferiority margin of -10%. Time to adequate sedation and time to loss of the eyelash reflex were longer with ciprofol than with propofol (p < 0.001). The diachronic changes of BIS and MAP in the ciprofol group decreased at a relatively slower rate during induction, indicating that ciprofol had a slower but smoother onset of action than propofol. The recovery time and extubation time were similar between groups. Ciprofol was associated with significantly lower incidences of injection pain, hypotension, and deep anesthesia than propofol. No patient in either group showed intraoperative awareness or postoperative cognitive decline. Conclusions: Ciprofol is non-inferior to propofol in terms of effectiveness and safety. It can be safely and effectively used for the induction and maintenance of general anesthesia in patients undergoing urological surgery.
Keywords: Ciprofol, Propofol, induction, Maintenance, Urological surgery
Received: 26 May 2025; Accepted: 26 Aug 2025.
Copyright: © 2025 Zhan, Xie, Lu and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Fan Zhang, Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan, Hebei Province, China
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