drugset / Trial / NCT04147416
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
Timeline
- Start
- 2019-11-22
- Primary completion
- 2020-05-31
- Completion
- 2020-07-03
Publications
- Liu Y, Zuo L, Li X, Nie Y, Chen C, Liu N, Chen M, Wu J, Guan X. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024 Oct 26;14(1):164. doi: 10.1186/s13613-024-01390-3.
- Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cipepofol | Small molecule | 0.3 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 1.5 mg/kg | Intravenous |
Indications
No indication recorded.