NCT04111159

A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy

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 Sedation/Anesthesia in Subjects Undergoing Fiberoptic Bronchoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.

Conditions

• Sedation or Anesthesia

Interventions

Type	Name	Description
DRUG	HSK3486	Subjects \< 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.
DRUG	Propofol	Subjects \< 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects \< 65 years old.

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-06-19
• Completion: 2020-07-27
• First posted: 2019-10-01
• Last updated: 2020-12-17

Locations

1 site across 1 country: China