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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04711837
Other study ID # HSK3486-304
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 11, 2021
Est. completion date April 20, 2022

Study information

Verified date October 2023
Source Haisco-USA Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date April 20, 2022
Est. primary completion date April 13, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HSK3486
HSK3486 for induction of general anesthesia.
Propofol
Propofol for induction of general anesthesia.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Haisco-USA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to the Disappearance of Eyelash Reflex Time from the end of the first administration of the study drug to the disappearance of eyelash reflex. From start of drug administration to disappearance of eyelash reflex (up to 5 minutes)
Other Number of Participants That Failed to Meet Successful Induction of General Anesthesia Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs From start of drug administration to MOAA/S =1 (up to 5 minutes)
Primary Number of Participants With Successful Anesthesia Induction The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S =1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone. From start of drug administration to MOAA/S =1 (up to 5 minutes)
Secondary Subjects' NRS Pain Score Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain). Subjects' NRS pain score at the time of study drug administration (Day 1) and recall of pain score in PACU. Up to 5 minutes
Secondary Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression. The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression between the time of successful induction and 15 minutes post initiation of study drug administration, or up to the beginning of second tracheal intubation attempt if it is a difficult condition and not beyond 15 minutes post initiation of study drug administration. 15 minutes from end of drug administration.
Secondary Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS =1). From start of drug administration to MOAA/S =1 (up to 5 minutes)
Secondary Time to Successful Induction of General Anesthesia. Time from the end of the first administration of the study drug to MOAA/S =1. From start of drug administration to MOAA/S =1 (up to 5 minutes)
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