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Efficacy and Safety of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults Undergoing Elective Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711837
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : January 18, 2022
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)
Estimated 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
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 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. Success rate of general anesthesia induction [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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) ]

Other Outcome Measures:
  1. Time to successful induction of general anesthesia. [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]
  2. Time to the disappearance of eyelash reflex [ Time Frame: From start of drug administration to disappearance of eyelash reflex (up to 5 minutes) ]
  3. Change of BIS during the period of anesthesia post study drug administration [ Time Frame: 15 minutes from end of drug administration. ]
  4. Use of the top-up study drug and rescue/remediation drugs. [ Time Frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes) ]

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


Contacts
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Contact: Yu-Ling Lai, MSN 732-266-4759 yuling.lai@haisco-usa.com

Locations
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United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85053
Contact: Aimee (Tapia) Upton    602-863-6363    atapia@azresearchcenter.com   
United States, California
Lotus Clinical Research, LLC Recruiting
Pasadena, California, United States, 91105
Contact: Anneliese Iniguez    626-397-2394    ainiguez@lotuscr.com   
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Michael Kampp    203-735-5118    michael.kampp@yale.edu   
United States, Florida
Phoenix Clinical Research, LLC Recruiting
Tamarac, Florida, United States, 33321
Contact: Steffanie Littleton    754-205-5000    s.littleton@phoenixclinical.com   
United States, Illinois
The University of Chicago Medicine Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Edward Fox    773-834-5234    efox1@bsd.uchicago.edu   
United States, New York
New York City Heath and Hospitals Not yet recruiting
New York, New York, United States, 10013
Contact: Raven Dwyer    718-918-7070    dwyerr1@nychhc.org   
Stony Brook University Hospital Not yet recruiting
Stony Brook, New York, United States, 11794
Contact: Sergio Bergese, MD    631-638-1214    Sergio.Bergese@stonybrookmedicine.edu   
United States, North Carolina
UNC Health Care System Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Karen Van Manen    919-843-5415    karen_vanmanen@med.unc.edu   
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Dan Miguel    919-613-2609    daniel.mungal@duke.edu   
United States, Ohio
The Ohio State University Research Foundation Recruiting
Columbus, Ohio, United States, 43210
Contact: Alberto Uribe, MD    614-293-3559    alberto.uribe@osumc.edu   
United States, Texas
HD Research Recruiting
Bellaire, Texas, United States, 77401
Contact: Daneshvari Solanki       Skolte@lotuscr.com   
Plano Surgical Hospital Recruiting
Plano, Texas, United States, 75093
Contact: Julie Greene       edionne@lotuscr.com   
Endeavor Clinical Trials, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Blanca Hernandez    551-999-6116    bhernandez@ergclinical.com   
United States, Utah
JBR Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Sandra Woods    801-261-2000    swoods@jbrutah.com   
Sponsors and Collaborators
Haisco-USA Pharmaceuticals, Inc.
Investigators
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Study Director: Wenfeng Miao, MD Haisco-USA Pharmaceuticals, Inc.
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
Last Update Posted: January 18, 2022
Last Verified: January 2022

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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