Clinical trial NCT04711837: Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Anesthesia
Elective surgery
Propofol
Lead sponsor: Haisco-USA Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Successful Anesthesia Induction
timeFrame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Secondary outcomes:
measure: Subjects' NRS Pain Score
timeFrame: Up to 5 minutes
measure: Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression.
timeFrame: 15 minutes from end of drug administration.
measure: Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale.
timeFrame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
measure: Time to Successful Induction of General Anesthesia.
timeFrame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Other outcomes:
measure: Time to the Disappearance of Eyelash Reflex
timeFrame: From start of drug administration to disappearance of eyelash reflex (up to 5 minutes)
measure: Number of Participants That Failed to Meet Successful Induction of General Anesthesia
timeFrame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Tamarac
country: United States
facility: Phoenix Clinical Research, LLC
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
city: New York
country: United States
facility: New York City Heath and Hospitals
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: UNC Health Care System
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Research Foundation
state: Ohio
city: Bellaire
country: United States
facility: HD Research
state: Texas
city: Plano
country: United States
facility: Plano Surgical Hospital
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
Study officials:
affiliation: Haisco-USA Pharmaceuticals, Inc.
name: William Daley, MD
role: STUDY_DIRECTOR
References: