AnesthesiaPhase 3NCT04711837
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery
A Phase 3 study testing HSK3486 and Propofol in people with Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- HSK3486 and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 13 sitesUnited States
- Study dates
- 11 Feb 2021to 20 Apr 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
HD Research
Bellaire, Texas, 77401
UNC Health Care System
Chapel Hill, North Carolina, 27599
The University of Chicago Medicine
Chicago, Illinois, 60637
The Ohio State University Research Foundation
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27705
New York City Heath and Hospitals
New York, New York, 10013
Lotus Clinical Research, LLC
Pasadena, California, 91105
Arizona Research Center
Phoenix, Arizona, 85053
Plano Surgical Hospital
Plano, Texas, 75093
JBR Clinical Research
Salt Lake City, Utah, 84107
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229
Stony Brook University Hospital
Stony Brook, New York, 11794
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321
About this study
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.
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.
- Conditions
- Anesthesia
- Being tested
- HSK3486, Propofol
- Keywords
- Anesthesia, Elective surgery, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
HSK3486 for induction of general anesthesia.
PropofolDrug
Also called Diprivan
Propofol for induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | HSK3486 for induction of general anesthesia. Receives: Drug: HSK3486 |
| Propofol | Active comparator | Propofol for induction of general anesthesia. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Secondary outcomes (4)
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.
Measured: Up to 8 hours
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.
Measured: 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).
Measured: 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.
Measured: From end of drug administration to MOAA/S ≤1 (up to 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start11 Feb 2021
- Primary completion13 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Daley, MD, Study director, Haisco-USA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711837
- Sponsor's protocol ID
- HSK3486-304
- Status last verified
- Sep 2025
- First submitted
- 12 Jan 2021
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No