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A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia

NCT04511728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2022-05-31

No results posted yet for this study

Summary

This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Conditions

  • Induction and Maintenance of General Anesthesia

Interventions

DRUG

HSK3486

The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h

DRUG

Propofol

The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2020-12-31
Completion
2021-01-25

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 NCT04511728 on ClinicalTrials.gov