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New sleep drug for surgery could rival propofol

NCT ID NCT04711837

Symptom relief Sponsor: Haisco-USA Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called HSK3486 to see if it works as well as propofol for putting adults to sleep before elective surgery. 255 people took part in a randomized, double-blind trial. The main goal was to see how many people had a successful start to anesthesia with HSK3486 compared to propofol.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK3486 injectable emulsion
What this could lead to
If successful, HSK3486 could offer a new option for putting people to sleep before surgery, possibly with less injection pain than current drugs.
What could go wrong
This is a late-stage trial, but the drug may not prove safer or more effective than propofol. Results may not apply to all surgeries or patient types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

255 people

The number who actually took part.

Started

Feb 2021

Finished

Apr 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia

Contacts and locations

Locations

  • Arizona Research Center

    Phoenix, Arizona, 85053, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas, 78229, United States

  • HD Research

    Bellaire, Texas, 77401, United States

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Lotus Clinical Research, LLC

    Pasadena, California, 91105, United States

  • New York City Heath and Hospitals

    New York, New York, 10013, United States

  • Phoenix Clinical Research, LLC

    Tamarac, Florida, 33321, United States

  • Plano Surgical Hospital

    Plano, Texas, 75093, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • The Ohio State University Research Foundation

    Columbus, Ohio, 43210, United States

  • The University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • UNC Health Care System

    Chapel Hill, North Carolina, 27599, United States

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