• Peng Liang, Meng Dai, Xiao Wang, Dongxin Wang, Mengchang Yang, Xuemei Lin, Xiaohua Zou, Ke Jiang, Yalan Li, Liangrong Wang, Wangning Shangguan, Jinghua Ren, and Hefan He.
• From the Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China (PL, MD, XW); Laboratory of Anesthesia and Critical Care Medicine, National-Local Joint Engineering Research Centre of Translational Medicine of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China (PL, MD, XW); Day Surgery Center, West China Hospital, Sichuan University, Chengdu, China (PL); Department of Anesthesiology, Peking University First Hospital, Beijing, China (DW); Department of Anesthesiology, Sichuan Provincial People's Hospital, Chengdu, China (MY); Department of Anesthesiology, West China Second University Hospital, Sichuan University, Chengdu, China (XL); Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, Guiyang, China (XZ, KJ); Department of Anesthesiology, The First Affiliated Hospital of Jinan University, Guangzhou, China (YL); Department of Anesthesiology, The 1st Affiliated Hospital of Wenzhou Medical University, Wenzhou, China (LW); Department of Anesthesiology, The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, China (WS); Department of Anesthesiology, The Second People's Hospital of Yibin, Yibin, China (JR); Department of Anesthesiology, The 2nd Affiliated Hospital, Fujian Medical University, Quanzhou, China (HH).
• Eur J Anaesthesiol. 2023 Jun 1; 40 (6): 399406399-406.

BackgroundHSK3486 (ciprofol) is a 2,6-disubstituted phenol derivative that acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABA A ) receptor.ObjectiveTo investigate the efficacy and safety of HSK3486 for general anaesthesia induction and maintenance.DesignA single-blinded, randomised, parallel-group, phase 3 trial.SettingInvolving 10 study centres, from November 24, 2020 to January 25, 2021.PatientsA total of 129 patients undergoing nonemergency, noncardiothoracic, and nonneurosurgical elective surgery.InterventionPatients 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 MeasuresNoninferiority 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.ResultsOf 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.ConclusionHSK3486 had a noninferior efficacy profile compared to propofol, exhibiting excellent tolerance.Trial RegistrationClinicaltrials.gov, identifier: NCT04511728.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society of Anaesthesiology and Intensive Care.

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