Phase
Condition
Anesthesia
Treatment
Propofol
HSK3486
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects undergoing elective surgery (nonemergency, noncardiothoracic, andnonintracranial surgery anticipated to last at least 1 hour ).
Males or females, aged ≥18 years old, with American Society of AnesthesiologistsPhysical Status (ASA PS) I to IV.
Body mass index (BMI) ≥18 kg/m2.
For all females of childbearing potential, negative pregnancy test at screening andbaseline. Additionally, females of childbearing potential must agree to use birthcontrol (such as condom, intrauterine device [IUD], abstinence) from the time ofconsent until 30 days post study drug administration.
Capable of understanding the procedures and methods of this study, willing to signan Informed Consent Form, and to complete this study in strict compliance with thestudy protocol.
Exclusion
Exclusion Criteria:
Contraindications to deep sedation/general anesthesia or a history of adversereaction to sedation/general anesthesia.
Known to be allergic to eggs, soy products, opioids and their antidotes, orpropofol; subject having contraindications to propofol, opioids, and theirantidotes.
Medical condition or evidence of increased sedation/general anesthesia risk.
Management risks of respiratory tract and judged by the investigator to beunsuitable for inclusion in the study.
Any medication that has the potential to interact synergistically with propofol orHSK3486, 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 orbaseline; lactating subjects; any subject planning to get pregnant within 1 monthafter the study (including the male subject's partner).
Judged by the investigator to have any other factors that make the subjectunsuitable for participation in the study.
Study Design
Connect with a study center
Arizona Research Center
Phoenix, Arizona 85053
United StatesSite Not Available
Arizona Research Center
Phoenix 5308655, Arizona 5551752 85053
United StatesSite Not Available
Lotus Clinical Research, LLC
Pasadena, California 91105
United StatesSite Not Available
Lotus Clinical Research, LLC
Pasadena 5381396, California 5332921 91105
United StatesSite Not Available
Yale University
New Haven, Connecticut 06511
United StatesSite Not Available
Phoenix Clinical Research, LLC
Tamarac, Florida 33321
United StatesSite Not Available
Phoenix Clinical Research, LLC
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
The University of Chicago Medicine
Chicago, Illinois 60637
United StatesSite Not Available
The University of Chicago Medicine
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
New York City Heath and Hospitals
New York, New York 10013
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesSite Not Available
New York City Heath and Hospitals
New York 5128581, New York 5128638 10013
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794
United StatesSite Not Available
UNC Health Care System
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Duke University
Durham, North Carolina 27705
United StatesSite Not Available
UNC Health Care System
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
The Ohio State University Research Foundation
Columbus, Ohio 43210
United StatesSite Not Available
The Ohio State University Research Foundation
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
HD Research
Bellaire, Texas 77401
United StatesSite Not Available
Plano Surgical Hospital
Plano, Texas 75093
United StatesSite Not Available
Endeavor Clinical Trials, LLC
San Antonio, Texas 78229
United StatesSite Not Available
HD Research
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Plano Surgical Hospital
Plano 4719457, Texas 4736286 75093
United StatesSite Not Available
Endeavor Clinical Trials, LLC
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
JBR Clinical Research
Salt Lake City, Utah 84107
United StatesSite Not Available
JBR Clinical Research
Salt Lake City 5780993, Utah 5549030 84107
United StatesSite Not Available

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