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

Anesthesia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711837
• Other study ID #: HSK3486-304
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia

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)