drugset / Trial / NCT04620031
A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation
RandomizedParallel-groupSingle-blindTreatment
Summary
This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group.
Timeline
- Start
- 2020-12-08
- Primary completion
- 2021-06-02
- Completion
- 2021-08-17
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, Peng Z, Liu S, Yu X, Zhu D, Zhang L, Wen J, An Y, Zhan L, Wang X, Kang Y, Pan A, Yan J, Zhang L, Liu F, Zeng J, Lin Q, Sun R, Yu J, Wang H, Yao L, Chen C, Liu N, Nie Y, Lyu J, Wu K, Wu J, Liu X, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial. Crit Care Med. 2023 Oct 1;51(10):1318-1327. doi: 10.1097/CCM.0000000000005920. Epub 2023 Jun 5.
- Liu Y, Chen C, Liu N, Tong L, Nie Y, Wu J, Liu X, Gao W, Tang L, Guan X. Efficacy and Safety of Ciprofol Sedation in ICU Patients with Mechanical Ventilation: A Clinical Trial Study Protocol. Adv Ther. 2021 Oct;38(10):5412-5423. doi: 10.1007/s12325-021-01877-6. Epub 2021 Aug 21.
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.