Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries

Phase 3 Completed 135 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a multi-center, randomized, double-blind, Propofol parallel-controlled phase III clinical study, with the primary objective of evaluating the efficacy of Ciprofol vs. Propofol for the induction of sedation/anesthesia in subjects undergoing gynecological outpatient surgeries and secondary objective of evaluating the safety of Ciprofol in subjects undergoing gynecological outpatient surgeries.

Timeline

Start: 2021-07-26
Primary completion: 2021-09-29
Completion: 2021-09-30

Publications

Xu J, Yang M, Zeng Y, Zou XH, Ren JH, Xia Z, Xie HH, Yu YH, Xu MJ, Chen W, Wang DX. Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial. Front Med (Lausanne). 2024 Apr 23;11:1360508. doi: 10.3389/fmed.2024.1360508. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.2 mg/kg	Intravenous
Comparator	Propofol	Small molecule	1 mg/kg	Intravenous

Indications

No indication recorded.