NCT04511728

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

A Multi-center, Randomized, Single-blind, Propofol Injectable Emulsion Parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion in the Induction of General Anesthesia in Patients Undergoing Elective Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Induction and Maintenance of General Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h
DRUG	Propofol	The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h

Timeline

• Start date: 2020-11-24
• Primary completion: 2020-12-31
• Completion: 2021-01-25
• First posted: 2020-08-13
• Last updated: 2022-05-31

Locations

1 site across 1 country: China