A Phase 3 interventional study of HSK3486 and Propofol in Anesthesia, sponsored by Haisco-USA Pharmaceuticals, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Haisco-USA Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
Haisco-USA Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HSK3486 for induction of general anesthesia.
Drug: HSK3486
Propofol for induction of general anesthesia.
Drug: Propofol
HSK3486 for induction of general anesthesia.
Propofol for induction of general anesthesia.
Also known as: Diprivan
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.
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: From end of drug administration to MOAA/S ≤1 (up to 5 minutes)
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.
Time frame: From end 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
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
| Milestone | HSK3486 | Propofol |
|---|---|---|
| Started | 170 | 85 |
| Completed | 168 | 83 |
| Not completed | 2 | 2 |
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.
| Participants | HSK3486 | Propofol |
|---|---|---|
| Number of Participants With Successful Anesthesia Induction | 163 | 81 |
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.
| Participants | HSK3486 | Propofol |
|---|---|---|
| Proportion of NRS ≥ 1 pain score on Day 1 — Proportion of NRS ≥1 and <4 pain score | 20 | 13 |
| Proportion of NRS ≥ 1 pain score on Day 1 — Proportion of NRS ≥4 pain score | 10 | 51 |
| Proportion of NRS ≥ 1 pain score on Day 1 — Proportion of NRS = 0 Pain score | 137 | 19 |
| Proportion of NRS ≥ 1 pain score on Day 1 — Missing NRS | 1 | 0 |
| Proportion of NRS ≥ 1 pain Score in PACU — Proportion of NRS ≥1 and <4 pain score | 27 | 17 |
| Proportion of NRS ≥ 1 pain Score in PACU — Proportion of NRS ≥4 pain score | 19 | 39 |
| Proportion of NRS ≥ 1 pain Score in PACU — Proportion of NRS = 0 Pain score | 113 | 21 |
| Proportion of NRS ≥ 1 pain Score in PACU — Missing NRS | 9 | 6 |
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.
| Participants | HSK3486 | Propofol |
|---|---|---|
| Successful Induction | 163 | 81 |
| Failed Induction | 5 | 2 |
The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1).
| Participants | HSK3486 | Propofol |
|---|---|---|
| Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale. | 30 | 64 |
Time from the end of the first administration of the study drug to MOAA/S ≤1.
| minutes | HSK3486 | Propofol |
|---|---|---|
| Time to Successful Induction of General Anesthesia. | 0.75 (0.6167 to 0.9000) | 0.62 (0.5167 to 0.8000) |
Time from the end of the first administration of the study drug to the disappearance of eyelash reflex.
| minutes | HSK3486 | Propofol |
|---|---|---|
| Time to the Disappearance of Eyelash Reflex | 0.92 (0.8333 to 1.0000) | 0.80 (0.7333 to 1.0000) |
Failed to meet successful induction of general anesthesia defined by the use of the Top-up Study Drug and Rescue/Remediation Drugs
| Participants | HSK3486 | Propofol |
|---|---|---|
| Number of Participants That Failed to Meet Successful Induction of General Anesthesia | 5 | 2 |
Collected over Adverse event reporting begins from the time of informed consent and ends 30 days after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HSK3486 | 0/168 (0%) | 0/168 (0%) | 47/168 (28%) |
| Propofol | 0/83 (0%) | 3/83 (3.6%) | 27/83 (32.5%) |
| Event | HSK3486 | Propofol |
|---|---|---|
| Pulmonary EmbolismCardiac disorders | 0/168 | 1/83 |
| Abdominal Wall HaematomaGastrointestinal disorders | 0/168 | 1/83 |
| Femur FractureMusculoskeletal and connective tissue disorders | 0/168 | 1/83 |
| Event | HSK3486 | Propofol |
|---|---|---|
| HypotensionVascular disorders | 47/168 | 27/83 |
| NauseaGastrointestinal disorders | 46/168 | 27/83 |
| Procedural PainInjury, poisoning and procedural complications | 32/168 | 19/83 |
| Age, Customized(Participants) | HSK3486 | Propofol | Total |
|---|---|---|---|
| Age Group (Years) — ≥65 | 27 | 14 | 41 |
| Age Group (Years) — <65 | 141 | 69 | 210 |
| Sex: Female, Male(Participants) | HSK3486 | Propofol | Total |
|---|---|---|---|
| Female | 119 | 57 | 176 |
| Male | 49 | 26 | 75 |
| Ethnicity (NIH/OMB)(Participants) | HSK3486 | Propofol | Total |
|---|---|---|---|
| Hispanic or Latino | 45 | 23 | 68 |
| Not Hispanic or Latino | 118 | 58 | 176 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Race (NIH/OMB)(Participants) | HSK3486 | Propofol | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 36 | 12 | 48 |
| White | 121 | 71 | 192 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 5 | 0 | 5 |
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Haisco-USA Pharmaceuticals, Inc.