NCT04147416

A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (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, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	HSK3486 0.1-0.2 /0.3 mg / kg group	Administered with HSK3486 at a loading dose of 0.1-0.2 mg/kg via intravenous pump. Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.
DRUG	Propofol 0.5-1.0/1.5 mg/kg group	Administered with Propofol at a loading dose of 0.5-1.0mg/kg via intravenous pump. Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.

Timeline

• Start date: 2019-11-22
• Primary completion: 2020-05-31
• Completion: 2020-07-03
• First posted: 2019-11-01
• Last updated: 2022-05-27

Locations

1 site across 1 country: China