Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
NCT ID: NCT04711837
Last Updated: 2025-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2021-02-11
2022-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HSK3486
HSK3486 for induction of general anesthesia.
HSK3486
HSK3486 for induction of general anesthesia.
Propofol
Propofol for induction of general anesthesia.
Propofol
Propofol for induction of general anesthesia.
Interventions
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HSK3486
HSK3486 for induction of general anesthesia.
Propofol
Propofol for induction of general anesthesia.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Haisco-USA Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Daley, MD
Role: STUDY_DIRECTOR
Haisco-USA Pharmaceuticals, Inc.
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HSK3486-304
Identifier Type: -
Identifier Source: org_study_id
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