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Trial record 2 of 6 for:    Induction of general anesthesia | HSK3486

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

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ClinicalTrials.gov Identifier: NCT04711837
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Haisco-USA Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 351 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 : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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




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) ]


Information from the National Library of Medicine

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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.

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: Carole Hodge, PhD 8584429884 carole.hodge@haisco-usa.com

Locations
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United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85053
Contact: Anneliese Iniguez       atapia@azresearchcenter.com   
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: Aimee (Tapia) Upton       atapia@azresearchcenter.com   
Sponsors and Collaborators
Haisco-USA Pharmaceuticals, Inc.
Investigators
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Study Director: Wenfeng Miao, MD Haisco-USA Pharmaceuticals, Inc.
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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: April 6, 2021
Last Verified: April 2021

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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