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

Completed · Phase 3

Conditions studied: Anesthesia

In brief

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.

Key facts

Study ID

NCT04711837

Run by

Haisco-USA Pharmaceuticals, Inc.

People needed

255

Starts

2021-02-11

Expected to finish

2022-04-20

Last updated by the study team

2025-10-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Lotus Clinical Research, LLC — Pasadena, California, United States
• Phoenix Clinical Research, LLC — Tamarac, Florida, United States
• The University of Chicago Medicine — Chicago, Illinois, United States
• New York City Heath and Hospitals — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• UNC Health Care System — Chapel Hill, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• The Ohio State University Research Foundation — Columbus, Ohio, United States
• HD Research — Bellaire, Texas, United States
• Plano Surgical Hospital — Plano, Texas, United States
• Endeavor Clinical Trials, LLC — San Antonio, Texas, United States
• JBR Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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