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

NCT04669821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-05-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2021-08-28
Completion
2021-10-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04669821 on ClinicalTrials.gov