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Published in: International Journal of Clinical Pharmacy 2/2023

Open Access 21-01-2023 | General Anesthesia | Research Article

Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial

Authors: Qianmei Zhu, Zhen Luo, Xia Wang, Dongxin Wang, Jun Li, Xinchuan Wei, Jun Tang, Shanglong Yao, Wen Ouyang, Wensheng Zhang, Yunxia Zuo, Xiao Wang, Jin Liu

Published in: International Journal of Clinical Pharmacy | Issue 2/2023

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Abstract

Background

Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor.

Aim

To determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery, and to assess its safety.

Method

A total of 109 patients undergoing selective non-emergency, non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for general anesthesia were enrolled. Ten patients per group were assigned to ciprofol-0.3, 0.4 and 0.5 mg/kg, and propofol-2.0 or 2.5 mg/kg groups, respectively to receive an intravenous bolus dose. An additional 20 patients were enrolled in the ciprofol-0.3, 0.5 or propofol-2.0 mg/kg groups. The primary outcome was the success rate of induction defined as a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) ≤ 1 after the initial bolus dose. The secondary outcomes included the time to reach MOAA/S ≤ 1, the time to loss of the eyelash reflex, the incidences and severity of adverse events (AEs).

Results

The success rates were 100% for all 5 groups. The mean time to MOAA/S ≤ 1 and the time to loss of the eyelash reflex were not different among the 5 groups, regardless of whether a top-up dose was needed. There were no significant differences in the incidences and severity of AEs in the dose ranges investigated of ciprofol vs. propofol.

Conclusion

The efficacy and safety of a single bolus dose of ciprofol-0.5 mg/kg for the general anesthesia induction in selective surgery patients was comparable to that of propofol-2.0 mg/kg.

Trial registration

Clinicaltrials.gov, NCT03698617, retrospectively registered.
Appendix
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Metadata
Title
Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial
Authors
Qianmei Zhu
Zhen Luo
Xia Wang
Dongxin Wang
Jun Li
Xinchuan Wei
Jun Tang
Shanglong Yao
Wen Ouyang
Wensheng Zhang
Yunxia Zuo
Xiao Wang
Jin Liu
Publication date
21-01-2023
Publisher
Springer International Publishing
Published in
International Journal of Clinical Pharmacy / Issue 2/2023
Print ISSN: 2210-7703
Electronic ISSN: 2210-7711
DOI
https://doi.org/10.1007/s11096-022-01529-x

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