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Trial record 1 of 1 for:    HSK3486-304
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Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery

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ClinicalTrials.gov Identifier: NCT04711837
Recruitment Status : Completed
First Posted : January 15, 2021
Results First Posted : May 26, 2023
Last Update Posted : October 6, 2023
Sponsor:
Information provided by (Responsible Party):
Haisco-USA Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: HSK3486 Drug: Propofol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing Elective Surgery.
Actual Study Start Date : February 11, 2021
Actual Primary Completion Date : April 13, 2022
Actual Study Completion Date : April 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Arm Intervention/treatment
Experimental: HSK3486
HSK3486 for induction of general anesthesia.
 Drug: HSK3486
HSK3486 for induction of general anesthesia.
Active Comparator: Propofol
Propofol for induction of general anesthesia.
 Drug: Propofol
Propofol for induction of general anesthesia.
Other Name: Diprivan


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Successful Anesthesia Induction [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]
    The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone.


Secondary Outcome Measures :
  1. Subjects' NRS Pain Score [ Time Frame: Up to 5 minutes ]
    Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain). Subjects' NRS pain score at the time of study drug administration (Day 1) and recall of pain score in PACU.

  2. Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. [ Time Frame: 15 minutes from end of drug administration. ]
    The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression between the time of successful induction and 15 minutes post initiation of study drug administration, or up to the beginning of second tracheal intubation attempt if it is a difficult condition and not beyond 15 minutes post initiation of study drug administration.

  3. Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]
    The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1).

  4. Time to Successful Induction of General Anesthesia. [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]
    Time from the end of the first administration of the study drug to MOAA/S ≤1.


Other Outcome Measures:
  1. Time to the Disappearance of Eyelash Reflex [ Time Frame: From start of drug administration to disappearance of eyelash reflex (up to 5 minutes) ]
    Time from the end of the first administration of the study drug to the disappearance of eyelash reflex.

  2. Number of Participants That Failed to Meet Successful Induction of General Anesthesia [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]
    Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to deep sedation/general anesthesia or a history of adverse reaction to 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 unsuitable for inclusion in the study.
  • Any medication that has the potential to interact synergistically with propofol or HSK3486, 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 or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).
  • Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711837


Locations
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United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85053
United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
United States, Florida
Phoenix Clinical Research, LLC
Tamarac, Florida, United States, 33321
United States, Illinois
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
United States, New York
New York City Heath and Hospitals
New York, New York, United States, 10013
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Health Care System
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27705
United States, Ohio
The Ohio State University Research Foundation
Columbus, Ohio, United States, 43210
United States, Texas
HD Research
Bellaire, Texas, United States, 77401
Plano Surgical Hospital
Plano, Texas, United States, 75093
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78229
United States, Utah
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Haisco-USA Pharmaceuticals, Inc.
Investigators
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Study Director: William Daley, MD Haisco-USA Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Haisco-USA Pharmaceuticals, Inc.:
Study Protocol  [PDF] July 30, 2021
Statistical Analysis Plan  [PDF] November 22, 2021

More Information
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Responsible Party: Haisco-USA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04711837    
Other Study ID Numbers: HSK3486-304
First Posted: January 15, 2021    Key Record Dates
Results First Posted: May 26, 2023
Last Update Posted: October 6, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haisco-USA Pharmaceuticals, Inc.:
Anesthesia
Elective surgery
Propofol
Additional relevant MeSH terms:
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Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics