Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia

作者：Peng Liang, Meng Dai, Xiao Wang, Dong‐Xin Wang, Mengchang Yang, Xuemei Lin, Xiaohua Zou, Ke Jiang, Yalan Li, Liangrong Wang, Wangning Shangguan, Jinghua Ren, He‐fan He · 发表于：European Journal of Anaesthesiology · 年份：2023 · DOI：10.1097/eja.0000000000001799 · 被引用次数：135 · 研究领域：Anesthesia and Sedative Agents、Cancer, Stress, Anesthesia, and Immune Response、Anesthesia and Neurotoxicity Research

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 anaest...