NCT04669821

A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation

A Multi-Center, Randomized, Open-Label, Propofol-Controlled Exploratory Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Long-Term Mechanical Ventilation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.

Conditions

• Sedation in Intensive Care

Interventions

Type	Name	Description
DRUG	HSK3486	Loading Dose：0.1 mg/kg，Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.
DRUG	Propofol	Loading Dose：0.5 mg/kg，Maintenance Dose：Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.

Timeline

• Start date: 2021-03-09
• Primary completion: 2021-08-28
• Completion: 2021-10-09
• First posted: 2020-12-17
• Last updated: 2022-05-27

Locations

1 site across 1 country: China