NCT03808844

A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects

A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between propofol and HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to provide reference for marketing registration of HSK3486.

Conditions

• Induction of Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed.
DRUG	Propofol	Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed

Timeline

• Start date: 2019-03-22
• Primary completion: 2019-08-14
• Completion: 2019-09-03
• First posted: 2019-01-18
• Last updated: 2019-09-13

Locations

1 site across 1 country: China