Trial · NCT05478174
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
NCT05478174, Phase 3, Completed, Haisco-USA Pharmaceuticals, Inc.; results first posted 2024-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia. Trials, record NCT05478174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05478174
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
- NCT number
- NCT05478174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 400 participants, actual
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Conditions
- General Anesthesia
- Interventions
- HSK3486, Propofol
- First posted
- 2022-07-28
- Last updated
- 2025-10-10
- Results first posted
- 2024-10-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate of General Anesthesia Induction | 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. |
| Secondary | Percentage 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 | The outcome is defined by all the following conditions: a) 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). b) No significant respiratory depression, such as apnea, prior to the administration of rocuronium bromide. c) No significant cardiac depression indicated by blood pressure decrease that requires intervention, i.e., vasopressors and/or IV fluid resuscitation. |
| Secondary | Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1 | From start of drug administration to MOAA/S ≤1 (up to 3 minutes) | 0 = No Pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-9 = Severe Pain 10 = Worst pain imaginable |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rate of General Anesthesia Induction | From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1 ( up to 5 minutes) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1 | From start of drug administration to MOAA/S ≤1 (up to 3 minutes) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate of General Anesthesia Induction | HSK3486 | 253 | Participants | ||
| Success Rate of General Anesthesia Induction | Propofol | 128 | Participants | ||
| Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression | HSK3486 | 88 | Participants | ||
| Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression | Propofol | 53 | Participants | ||
| Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1 | HSK3486 | 42 | Participants | ||
| Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1 | Propofol | 58 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HSK3486 | 267 | |
| Overall Study | STARTED | Propofol | 133 | |
| Overall Study | Dosed | HSK3486 | 255 | |
| Overall Study | Dosed | Propofol | 129 | |
| Overall Study | Full Analysis Set | HSK3486 | 255 | |
| Overall Study | Full Analysis Set | Propofol | 128 | |
| Overall Study | Safety Set | HSK3486 | 255 | |
| Overall Study | Safety Set | Propofol | 129 | |
| Overall Study | COMPLETED | HSK3486 | 254 | |
| Overall Study | COMPLETED | Propofol | 129 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | HSK3486 | 52 | 255 | |
| other | Hypotension | Vascular disorders | Propofol | 29 | 129 | |
| other | Nausea | Gastrointestinal disorders | HSK3486 | 52 | 255 | |
| other | Nausea | Gastrointestinal disorders | Propofol | 25 | 129 | |
| other | Procedural Pain | Injury, poisoning and procedural complications | HSK3486 | 38 | 255 | |
| other | Procedural Pain | Injury, poisoning and procedural complications | Propofol | 24 | 129 | |
| other | Asthenia | General disorders | HSK3486 | 36 | 255 | |
| other | Asthenia | General disorders | Propofol | 23 | 129 | |
| other | Hypertension | Vascular disorders | HSK3486 | 30 | 255 | |
| other | Hypertension | Vascular disorders | Propofol | 15 | 129 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HSK3486 | 0 | 255 |
| Total, all-cause mortality | Propofol | 0 | 129 |
| Total, other adverse events | HSK3486 | 178 | 255 |
| Total, other adverse events | Propofol | 89 | 129 |
| Total, serious adverse events | HSK3486 | 6 | 255 |
| Total, serious adverse events | Propofol | 2 | 129 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
HSK3486 vs Propofol: Percentage of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression | Trial comparisons |
| HSK3486 vs Propofol: Success Rate of General Anesthesia Induction | Trial comparisons |
| HSK3486 vs Propofol: Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1 | Trial comparisons |
| HSK3486 vs Propofol: deaths from any cause | Trial comparisons |
| HSK3486 vs Propofol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05478174
GET https://conductscience.org/api/trials/v1/NCT05478174/events?page=2