Status:
COMPLETED
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
Lead Sponsor:
Haisco-USA Pharmaceuticals, Inc.
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 e...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04711837
Start Date
February 11 2021
End Date
April 20 2022
Last Update
October 10 2025
Active Locations (13)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
3
Phoenix Clinical Research, LLC
Tamarac, Florida, United States, 33321
4
The University of Chicago Medicine
Chicago, Illinois, United States, 60637