Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery

Last updated: October 4, 2023
Sponsor: Haisco-USA Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Anesthesia

Treatment

Propofol

HSK3486

Clinical Study ID

NCT04711837
HSK3486-304
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects undergoing elective surgery (nonemergency, noncardiothoracic, andnonintracranial surgery anticipated to last at least 1 hour ).
  • Males or females, aged ≥18 years old, with American Society of AnesthesiologistsPhysical Status (ASA PS) I to IV.
  • Body mass index (BMI) ≥18 kg/m2.
  • For all females of childbearing potential, negative pregnancy test at screening andbaseline. Additionally, females of childbearing potential must agree to use birthcontrol (such as condom, intrauterine device [IUD], abstinence) from the time ofconsent until 30 days post study drug administration.
  • Capable of understanding the procedures and methods of this study, willing to sign anInformed Consent Form, and to complete this study in strict compliance with the studyprotocol.

Exclusion

Exclusion Criteria:

  • Contraindications to deep sedation/general anesthesia or a history of adverse reactionto sedation/general anesthesia.
  • Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol;subject having contraindications to propofol, opioids, and their antidotes.
  • Medical condition or evidence of increased sedation/general anesthesia risk.
  • Management risks of respiratory tract and judged by the investigator to be unsuitablefor inclusion in the study.
  • Any medication that has the potential to interact synergistically with propofol orHSK3486, including but not limited to all sedatives and hypnotics.
  • Laboratory parameters significantly out of range at screening.
  • Female subjects with a positive pregnancy test (serum or urine) at screening orbaseline; lactating subjects; any subject planning to get pregnant within 1 monthafter the study (including the male subject's partner).
  • Judged by the investigator to have any other factors that make the subject unsuitablefor participation in the study.

Study Design

Total Participants: 255
Treatment Group(s): 2
Primary Treatment: Propofol
Phase: 3
Study Start date:
February 11, 2021
Estimated Completion Date:
April 20, 2022

Connect with a study center

  • Arizona Research Center

    Phoenix, Arizona 85053
    United States

    Site Not Available

  • Lotus Clinical Research, LLC

    Pasadena, California 91105
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Phoenix Clinical Research, LLC

    Tamarac, Florida 33321
    United States

    Site Not Available

  • The University of Chicago Medicine

    Chicago, Illinois 60637
    United States

    Site Not Available

  • New York City Heath and Hospitals

    New York, New York 10013
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • UNC Health Care System

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • The Ohio State University Research Foundation

    Columbus, Ohio 43210
    United States

    Site Not Available

  • HD Research

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Plano Surgical Hospital

    Plano, Texas 75093
    United States

    Site Not Available

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

  • JBR Clinical Research

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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