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Clinical Trial
. 2023 Jun 1;40(6):399-406.
doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.

Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial

Peng Liang  1 , Meng Dai, Xiao Wang, Dongxin Wang, Mengchang Yang, Xuemei Lin, Xiaohua Zou, Ke Jiang, Yalan Li, Liangrong Wang, Wangning Shangguan, Jinghua Ren, Hefan He
Affiliations
Clinical Trial

Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial

Peng Liang et al. Eur J Anaesthesiol. .

Abstract

Background: HSK3486 (ciprofol) is a 2,6-disubstituted phenol derivative that acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABA A ) receptor.

Objective: To investigate the efficacy and safety of HSK3486 for general anaesthesia induction and maintenance.

Design: A single-blinded, randomised, parallel-group, phase 3 trial.

Setting: Involving 10 study centres, from November 24, 2020 to January 25, 2021.

Patients: A total of 129 patients undergoing nonemergency, noncardiothoracic, and nonneurosurgical elective surgery.

Intervention: Patients were randomly assigned at a 2:1 ratio into HSK3486 or propofol groups, to receive HSK3486 (0.4 mg kg -1 ) or propofol (2.0 mg kg -1 ) for induction before a maintenance infusion at initial rates of 0.8 and 5.0 mg kg -1 h -1 , and were adjusted to maintain a bispectral index (BIS) of 40-60 until the end of surgery.

Main outcome measures: Noninferiority between the drugs was evaluated as the lower limit of the 95% confidence interval (CI) for the between-group difference in the success rate of anesthetic maintenance (primary outcome) >-8%. Secondary outcomes included successful anaesthetic induction, full alertness and spontaneous breathing recovery, time until leaving the postanaesthesia care unit and changes in BIS. Safety profiles were also measured.

Results: Of 129 enrolled patients, 128 completed the trial, with 86 in the HSK3486 group and 42 in the propofol group. The success rate for the maintenance of general anaesthesia was 100% for both groups, and noninferiority of HSK3486 was confirmed (95% CI -4.28% to 8.38%). No significant differences were found between the two groups of patients with regard to secondary outcomes (all P > 0.05). There appeared to be a comparable incidence of treatment for emergency adverse events (TEAEs) (80.2% vs. 81.0%, P = 1.000) and drug-related TEAEs (57.0% vs. 64.3%, P = 0.451) in the HSK3486 and propofol groups.

Conclusion: HSK3486 had a noninferior efficacy profile compared to propofol, exhibiting excellent tolerance.

Trial registration: Clinicaltrials.gov, identifier: NCT04511728.

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Figures

Fig. 1
Fig. 1
Flow chart of the study.
Fig. 2
Fig. 2
Changes in BIS during the induction and maintenance phases of general anaesthesia in the two groups.
See this image and copyright information in PMC

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References

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