drugset
drugset / Trial / NCT05478174

Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia

NCT05478174 ↗

Phase 3 Completed 400 enrolled Haisco-USA Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.

Timeline

Start
2022-07-26
Primary completion
2023-11-07
Completion
2023-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.4 mg/kg Intravenous
Comparator Propofol Small molecule 2 mg/kg Intravenous

Indications

No indication recorded.