Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial
Qianmei Zhu, Zhen Luo, Xia Wang, Dong‐Xin Wang, Junmin Li, Xinchuan Wei, Jun Tang, Shanglong Yao, Wen Ouyang, Wensheng Zhang, Yunxia Zuo, Xiao Wang, Jin Liu, Xiao Wang, Jin Liu
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.