General AnesthesiaPhase 3NCT05486416
Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery
A Phase 3 study testing HSK3486 and Propofol in people with General Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 28 sites in 3 countries.
Trial summary
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 [±5] seconds for first dose, an additional 1.0 mg/kg if needed) in success of… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- HSK3486 and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 12 Jan 2024to 23 Jul 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must satisfy all of the following criteria at the screening visit:
- Subjects undergoing elective surgery (non-emergency, non-cardiothoracic, and non-intracranial surgery anticipated to last at least 1 hour) requiring endotracheal intubation and inhalation general anesthesia during the maintenance period. Duration of surgery is defined as time from study drug administration to time of transfer from operating room to recovery room or PACU.
- Males or females, aged ≥18 years old, with ASA PS I to IV (Appendix 6). For ASA-PS IV subjects, clinical status must be optimized at time of preoperative anesthesia evaluation per judgement of the anesthesiologist.
- BMI ≥18 kg/m2.
- Vital signs at screening: RR ≥10 and ≤24 breaths/min; SpO2 ≥92% in ambient air; SBP ≥90 and ≤160 mmHg; DBP ≥55 and ≤ 100 mmHg; HR ≥55 (or ≥50 if subjects are on beta blockers) and ≤100 beats/min.
- For all women of childbearing potential, negative serum pregnancy test within the screening period and negative urine pregnancy test at baseline (Day 1). Additionally, women of childbearing potential* and male subjects with female partners of childbearing potential must agree to use contraception as defined in 7.3.4 from the time of consent until 30 days post study drug administration.
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- For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e., thyroxine), or subjects suspected to have thyroid dysfunction based on clinical laboratory and physical exam, a TSH must drawn and be within normal levels.
- Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form (ICF), and able to complete this study in strict compliance with the study protocol.
- Willing to comply with the site's COVID guidelines and testing requirements as applicable.
- Patients with psychiatric/mental disorders must be considered stable on treatment (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) per investigator judgement, and no hospitalizations and urgent care due to the underlying psychiatric pathology for at least 12 months.
- Women are considered of childbearing potential until becoming post-menopausal, unless she had a documented hysterectomy or bilateral oophorectomy / salpingo-oophorectomy. A woman is considered to be post-menopausal if she had no menses for at least 12 consecutive months (without an alternative medical cause).
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; subjects having contraindications to propofol, opioids, and their antidotes. In cases where the only previous reaction to opioids was itching or nausea, subjects need not be excluded if the investigator believes the subject is not truly allergic to opioids.
- Medical condition or evidence of increased sedation/general anesthesia risk as follows:
- Cardiovascular disorder: uncontrolled hypertension (SBP >160 mmHg and/or DBP >100 mmHg) with or without antihypertensive therapy (antihypertensive therapy should be stable for 1 month prior to screening), serious arrhythmia (including the subjects with implanted pace makers), unstable heart failure, Adams-Stokes syndrome (i.e., syncope or near-syncope due to cardiac arrythmia), unstable angina, myocardial infarction occurring within 6 months prior to screening, history of tachycardia/bradycardia requiring medications, third degree atrioventricular block or QT interval corrected for HR using Fridericia's formula (QTcF) ≥450 ms for males and ≥470 ms for females.
- History of severe obstructive lung disease (i.e., forced expiratory volume in 1 second [FEV1] <50% predicted), history of bronchospasm requiring treatment in a hospital emergency room or hospitalization occurring within 3 months prior to screening, developing acute respiratory tract infection within 2 weeks prior to baseline (such as symptoms of fever, shortness of breath, wheezing, nasal congestion, and cough).
- Cerebrovascular disease: subject with a history of serious craniocerebral injury, convulsion, seizure disorder, intracranial hypertension, cerebral aneurysm, or stroke.
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- Patients with psychiatric/mental disorders who have not been on a stable treatment regimen (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) per investigator judgement, for at least 12 months or who have been hospitalized or had emergent/urgent care due to the underlying psychiatric pathology within the last 12 months.
- Uncontrolled clinically significant conditions of liver (e.g., severe hepatic insufficiency defined as Childs-Pugh class C), kidney, gastrointestinal tract, blood system, nervous system, or metabolic system diseases, judged by the investigator to be unsuitable for involvement in the study.
- History of uncontrolled diabetes in the opinion of the investigator.
- History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking >2 units of alcohol (1 unit = 360 mL of beer or 45 mL of spirit with a strength of 40% or 150 mL of wine).
- History of drug abuse that, in the opinion of the investigator, may confound the interpretation of safety or efficacy in a study subject.
- For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e., thyroxine), or subjects suspected to have thyroid dysfunction based on clinical laboratory and physical exam who has a TSH value outside the normal range.
- Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study as follows:
- Asthma must be stable: stable doses of asthma medications for the past 6 months, no requirement for rescue inhalers or oral steroids within past 6 months, not evaluated in emergency department, urgent care, or hospitalized for an asthma attack within past 1 year.
- History (or family history) of malignant hyperthermia.
- Any previous failure of tracheal intubation.
- Judged to have a difficult airway for endotracheal intubation in the opinion of the Investigator based on parameters such as modified Mallampati score (Grade III or IV [Appendix 7]), neck mobility, short thyromental distance, and/or history of difficult intubation).
- Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics (e.g., benzodiazepines and opioids), taken within 5 half-lives prior to Day 1.
- Laboratory parameters measured at screening with the following levels:
- Neutrophil count ≤1.5 x 109/L
- Platelet count <80 x 109/L
- Hemoglobin <90 g/L (without blood transfusion within 14 days)
- Alanine transaminase and/or aspartate transaminase ≥2.0 x upper limit of normal (ULN)
- Total bilirubin ≥2.0 x ULN
- Severe renal impairment defined by creatinine clearance (CrCl) ≤30 mL/min
- Female subjects with a positive pregnancy test at screening (serum) or baseline (urine); 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
28 sites in 3 countries.
28 sites in 3 countries
United States21 sites
Michigan Medicine
Ann Arbor, Michigan, 48109
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
First Surgical Hospital
Bellaire, Texas, 77401
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
Legent Orthopedic Hospital
Carrollton, Texas, 75006
The Ohio State University Wexner Medical Center - University Hospital
Columbus, Ohio, 43210
M3-Emerging Medical Research, LLC
Durham, North Carolina, 27704
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
North Alabama Medical Center
Florence, Alabama, 35630
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Hermann Village
Houston, Texas, 77043
University of Iowa Hospitals and Clinics (Dept of Anesthesia)
Iowa City, Iowa, 52242
U of L Health, University of Louisville Hospital
Louisville, Kentucky, 40202
University of Miami Hospital
Miami, Florida, 33136
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
Gulfcoast Research Institute
Sarasota, Florida, 34232
Helen Keller Hospital
Sheffield, Alabama, 35660
EBGS Clinical Research Center
Snellville, Georgia, 30078
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321
ForCare Clinical Research
Tampa, Florida, 33613
Spain4 sites
Hospital Clinic De Barcelona
Barcelona
Hospital General Universitario De Ciudad Real
Ciudad Real
Universidad de Navarra - Clinica Universidad de Navarra en Pamplona
Pamplona
Hospital Clinico Universitario de Valencia (CHUV)
Valencia
Poland3 sites
Uniwersytecki Szpital Kliniczny W Opolu
Opole
Państwowy Instytut Medyczny Mswia - Klinika Anestezjologii I Intensywnej Terapii
Warsaw
Spsk Nr 1 Im. Prof. S. Szyszko
Zabrze
About this study
Official title: A Global 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
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 [±5] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
Read the detailed description
This is a global 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 with endotracheal intubation.
After screening, eligible subjects will be randomized in a 2:1 ratio to receive either HSK3486 0.4/0.2 mg/kg (i.e., 0.4 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 0.2 mg/kg dose over 10 [±2] seconds if needed) or propofol 2.0/1.0 mg/kg (i.e., 2.0 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 1.0 mg/kg dose over 10 [±2]seconds if needed) in a blinded manner. Enrolled subjects will be stratified by American Society of Anesthesiologists Physical Status (ASA-PS; I-II and III-IV), age (<65 and ≥65 years), and Body Mass Index (BMI <35 and ≥35 kg/m2). Endotracheal intubation will be performed after adequate anesthetic induction (Modified Observer's Assessment of Awareness/Sedation [MOAA/S] ≤1) (Appendix 1) has been achieved and administration of neuromuscular blocking agent.
Before surgery, premedication is allowed except for sedative-hypnotic or analgesic drugs. Premedication should be recorded if used.
Prior to administration of the study drug in the operating room, the preoperative readiness of each subject will be confirmed. Oxygen will be supplied through a facemask (oxygen flow rate: ≥4 L/min) at least 2 minutes before study drug administration. Subsequently, the investigator can adjust the oxygen flow according to the specific situation of the subject and maintenance IV solution (normal saline [NS], lactated ringer's [LR], or 5% dextrose) will be administrated through IV infusion. Throughout the pre-induction and induction periods, a timing device must be used to allow accuracy and sequencing of necessary assessments.
- Conditions
- General Anesthesia
- Being tested
- HSK3486, 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 for general anesthesia induction | Experimental | HSK3486 for induction of general anesthesia Receives: Drug: HSK3486 |
| Propofol for general anesthesia induction | 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.
Success Rate of General Anesthesia Induction
- Induction success (MOAA/S ≤1) after administration of the study drug, and
- One or less top-up doses required without using any rescue drugs.
Measured: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)
Secondary outcomes (2)
Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression
The outcome is defined by all the following conditions:
- Desired depth of anesthesia for general elective surgery is defined if all following criteria are met: i) No clinical signs of inadequate depth of anesthesia, such as lacrimation, movement, vomiting, coughing, laryngospasm, bucking, swallowing reflex or bronchospasm etc. ii) No blood pressure (SBP, DBP, or MAP) increases more than 20% from baseline in response to any major operational procedures or noxious stimulus in defined period. iii) Subjects maintain desired depth of anesthesia for general elective surgery with BIS as an objective assessment (after reaching initial lowest value, BIS remains sustainable level at not more than 60).
- No significant respiratory depression, such as apnea, prior to the administration of rocuronium bromide.
- No significant cardiac depression indicated by blood pressure decrease that requires intervention, i.e., vasopressors and/or IV fluid resuscitation.
Measured: 15 minutes from end of drug administration
Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1
0 = No Pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-9 = Severe Pain 10 = Worst pain imaginable
Measured: From start of the drug administration to MOAA/S ≤1 (up to 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start12 Jan 2024
- Primary completion23 Jul 2024
- Study completion23 Jul 2024
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 General 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
- Model description
- Surgical pre-induction analgesia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486416
- Sponsor's protocol ID
- HSK3486-309
- Status last verified
- Sep 2025
- First submitted
- 1 Aug 2022
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global 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
- ClinicalTrials.gov ID
- NCT05486416
- Acronym / sponsor ID
- HSK3486-309
- Conditions
- General Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to Propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 [±5] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.
Detailed description
This is a global 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 with endotracheal intubation.
After screening, eligible subjects will be randomized in a 2:1 ratio to receive either HSK3486 0.4/0.2 mg/kg (i.e., 0.4 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 0.2 mg/kg dose over 10 [±2] seconds if needed) or propofol 2.0/1.0 mg/kg (i.e., 2.0 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 1.0 mg/kg dose over 10 [±2]seconds if needed) in a blinded manner. Enrolled subjects will be stratified by American Society of Anesthesiologists Physical Status (ASA-PS; I-II and III-IV), age (<65 and ≥65 years), and Body Mass Index (BMI <35 and ≥35 kg/m2). Endotracheal intubation will be performed after adequate anesthetic induction (Modified Observer's Assessment of Awareness/Sedation [MOAA/S] ≤1) (Appendix 1) has been achieved and administration of neuromuscular blocking agent.
Before surgery, premedication is allowed except for sedative-hypnotic or analgesic drugs. Premedication should be recorded if used.
Prior to administration of the study drug in the operating room, the preoperative readiness of each subject will be confirmed. Oxygen will be supplied through a facemask (oxygen flow rate: ≥4 L/min) at least 2 minutes before study drug administration. Subsequently, the investigator can adjust the oxygen flow according to the specific situation of the subject and maintenance IV solution (normal saline [NS], lactated ringer's [LR], or 5% dextrose) will be administrated through IV infusion. Throughout the pre-induction and induction periods, a timing device must be used to allow accuracy and sequencing of necessary assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Surgical pre-induction analgesia
| Arm | Type | Receives |
|---|---|---|
| HSK3486 for general anesthesia induction | Experimental | Drug: HSK3486HSK3486 for induction of general anesthesia |
| Propofol for general anesthesia induction | Active comparator | Drug: PropofolPropofol for induction of general anesthesia |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must satisfy all of the following criteria at the screening visit:
Key exclusion criteria (27 listed)
- 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; subjects having contraindications to propofol, opioids, and their antidotes. In cases where the only previous reaction to opioids was itching or nausea, subjects need not be excluded if the investigator believes the subject is not truly allergic to opioids.
- Medical condition or evidence of increased sedation/general anesthesia risk as follows:
- Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study as follows:
- Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics (e.g., benzodiazepines and opioids), taken within 5 half-lives prior to Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK3486HSK3486 for induction of general anesthesia | Drug | HSK3486 for general anesthesia induction |
| PropofolAlso: DiprivanPropofol for induction of general anesthesia | Drug | Propofol for general anesthesia induction |
Primary outcome
Success Rate of General Anesthesia Induction
Time frame: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)
1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.
2 secondary outcomes
Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression
Time frame: 15 minutes from end of drug administration
Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1
Time frame: From start of the drug administration to MOAA/S ≤1 (up to 3 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK3486 and Propofol in people with General Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Spain, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of General Anesthesia Induction (time frame: From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1( up to 5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.