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A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

NCT04147416 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-05-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sichuan 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
2019-11-22
Primary Completion
2020-05-31
Completion
2020-07-03

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 NCT04147416 on ClinicalTrials.gov