A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia

Phase 3 Completed 129 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Timeline

Start: 2020-11-24
Primary completion: 2020-12-31
Completion: 2021-01-25

Outcome

Met primary endpoint

paper 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%). PMID 36647565 ↗

Publications

Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. 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. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.8 mg/kg	—
Comparator	Propofol	Small molecule	5 mg/kg	—

Indications

No indication recorded.