Efficacy and Safety of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults Undergoing Elective Surgery.

• Sponsor: Haisco-USA Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04711837
• Collaborator: (none)
• Enrollment: 261
• Locations: 13
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site: 20.1
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: HSK3486; Drug: Propofol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 261 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Feb 11, 2021
• Actual Primary Completion Date: Apr 13, 2022
• Actual Study Completion Date: Apr 20, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Success rate of general anesthesia induction [From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]

Secondary Outcome Measures

1. Proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression. [15 minutes from end of drug administration.]

2. Proportion of subjects with any injection-site pain on Numeric Rating Scale. [From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]

Other Outcome Measures

1. Time to successful induction of general anesthesia. [From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]

2. Time to the disappearance of eyelash reflex [From start of drug administration to disappearance of eyelash reflex (up to 5 minutes)]

3. Change of BIS during the period of anesthesia post study drug administration [15 minutes from end of drug administration.]

4. Use of the top-up study drug and rescue/remediation drugs. [From start of drug administration to MOAA/S ≤1 (up to 5 minutes)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85053
2	Lotus Clinical Research, LLC	Pasadena	California	United States	91105
3	Phoenix Clinical Research, LLC	Tamarac	Florida	United States	33321
4	The University of Chicago Medicine	Chicago	Illinois	United States	60637
5	New York City Heath and Hospitals	New York	New York	United States	10013
6	Stony Brook University Hospital	Stony Brook	New York	United States	11794
7	UNC Health Care System	Chapel Hill	North Carolina	United States	27599
8	Duke University	Durham	North Carolina	United States	27705
9	The Ohio State University Research Foundation	Columbus	Ohio	United States	43210
10	HD Research	Bellaire	Texas	United States	77401
11	Plano Surgical Hospital	Plano	Texas	United States	75093
12	Endeavor Clinical Trials, LLC	San Antonio	Texas	United States	78229
13	JBR Clinical Research	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Haisco-USA Pharmaceuticals, Inc.

Investigators

• Study Director: Wenfeng Miao, MD, Haisco-USA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haisco-USA Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04711837
• Other Study ID Numbers: HSK3486-304
• First Posted: Jan 15, 2021
• Last Update Posted: May 2, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haisco-USA Pharmaceuticals, Inc.: Anesthesia; Elective surgery; Propofol
• Additional relevant MeSH terms: Propofol

Study Results

No Results Posted as of May 2, 2022