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HSK3486 for General Anesthesia
Phase 3
Waitlist Available
Research Sponsored by Haisco-USA Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes from end of drug administration
Awards & highlights
Summary
This trialshows HSK3486 is as effective as propofol for inducing general anesthesia in adults undergoing elective surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes from end of drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes from end of drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Success rate of general anesthesia induction
Secondary outcome measures
Proportion of subjects with any injection-site pain on Numeric Rating Scale
Proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression
Side effects data
From 2022 Phase 3 trial • 255 Patients • NCT0471183728%
Hypotension
27%
Nausea
19%
Procedural Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
HSK3486
Propofol
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HSK3486Experimental Treatment1 Intervention
HSK3486 for general anesthesia induction
Group II: PropofolActive Control1 Intervention
Propofol for general anesthesia induction
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HSK3486
2019
Completed Phase 3
~1630
Find a Location
Who is running the clinical trial?
Haisco-USA Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
696 Total Patients Enrolled
2 Trials studying General Anesthesia
441 Patients Enrolled for General Anesthesia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a recent history of heavy drinking.You have a mental illness like schizophrenia or mania, but you've been receiving treatment for at least 1 year without being hospitalized or needing urgent care.You have uncontrolled health conditions affecting your liver, kidney, digestive system, blood, nervous system, or metabolism.You are scheduled to have a surgery that requires general anesthesia and lasts for at least one hour, but it is not an emergency, cardiothoracic, or intracranial surgery.If you have schizophrenia or mania, you need to be stable on medication for at least a year and not have been hospitalized or required urgent care during that time.If you are a woman who can become pregnant, you need to take a pregnancy test before the study and on the first day of the study. You also need to use effective birth control during the study and for 30 days after.You agree to follow the site's rules for preventing the spread of COVID-19, including any required testing.Women who can't get pregnant naturally because they've had surgery to remove their reproductive organs or have gone through menopause (stopped having regular periods for at least a year) are included.You are 18 years or older and your overall health status falls under categories I to IV according to ASA-PS guidelines. If you fall under category IV, your condition must be improved as per the anesthesiologist's recommendation.You have a history of drug abuse that could make it difficult to understand if the treatment is working properly or could cause safety issues.Your BMI (a measure of body weight) is 18 or higher. Your vital signs measured at screening are within normal ranges: breathing rate between 10 to 24 breaths per minute, oxygen levels in your blood are at least 92% without extra oxygen, your blood pressure is between 90 to 160 mmHg (systolic) and 55 to 100 mmHg (diastolic), and your heart rate is between 55 to 100 beats per minute (or 50 to 100 beats per minute if you're taking beta blockers).You understand the study's procedures and agree to follow the rules outlined in the study's plan. You are also able to sign a form indicating your agreement to participate.You are allergic to eggs, soy products, opioids or propofol, or you cannot take propofol, opioids or their antidotes for medical reasons.You have been diagnosed with schizophrenia or mania and have not been stable on treatment, or have been hospitalized or received emergency care for these conditions within the past year.
Research Study Groups:
This trial has the following groups:- Group 1: HSK3486
- Group 2: Propofol
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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