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

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.

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Propofol; Drug: HSK3486

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
  • Florida
    • Tamarac, Florida, United States, 33321
      • Phoenix Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine
  • New York
    • New York, New York, United States, 10013
      • New York City Heath and Hospitals
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Health Care System
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Research Foundation
  • Texas
    • Bellaire, Texas, United States, 77401
      • HD Research
    • Plano, Texas, United States, 75093
      • Plano Surgical Hospital
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • JBR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK3486; HSK3486 for induction of general anesthesia.	Drug: HSK3486; HSK3486 for induction of general anesthesia.
Active Comparator: Propofol; Propofol for induction of general anesthesia.	Drug: Propofol; Propofol for induction of general anesthesia.; Other Names: Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Haisco-USA Pharmaceuticals, Inc.
• Investigators: Study Director: William Daley, MD, Haisco-USA Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2021
• Primary Completion (Actual): April 13, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Propofol; Anesthesia; Elective surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: HSK3486-304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No