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HSK3486 for General Anesthesia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Miami Hospital, Miami, FLGeneral AnesthesiaHSK3486 - Drug
Eligibility
18 - 99
All Sexes
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Study Summary

This trialshows HSK3486 is as effective as propofol for inducing general anesthesia in adults undergoing elective surgery.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Monitored Anesthetic Care (MAC)/Local
1
General
1
Treatment A: HSK3486 dose 1

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 15 minutes from end of drug administration

15 minutes from end of drug administration
Proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, AND without significant cardiac and respiratory depression
From start of drug administration to MOAA/S ≤1 (up to 3 minutes)
Proportion of subjects with any injection-site pain on Numeric Rating Scale
From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1 ( up to 5 minutes)
Success rate of general anesthesia induction

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Monitored Anesthetic Care (MAC)/Local
1
General
1
Treatment A: HSK3486 dose 1

Trial Design

2 Treatment Groups

Propofol
1 of 2
HSK3486
1 of 2

Active Control

Experimental Treatment

399 Total Participants · 2 Treatment Groups

Primary Treatment: HSK3486 · No Placebo Group · Phase 3

HSK3486
Drug
Experimental Group · 1 Intervention: HSK3486 · Intervention Types: Drug
Propofol
Drug
ActiveComparator Group · 1 Intervention: Propofol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HSK3486
2019
Completed Phase 3
~1630

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 15 minutes from end of drug administration

Who is running the clinical trial?

Haisco-USA Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
702 Total Patients Enrolled
2 Trials studying General Anesthesia
441 Patients Enrolled for General Anesthesia

Eligibility Criteria

Age 18 - 99 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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.
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.
References

Frequently Asked Questions

Are there short-term or long-term dangers to taking HSK3486?

"Although this is only a phase 3 trial, there is some evidence of efficacy and HSK3486's safety has been corroborated multiple times. Therefore, it receives a score of 3." - Anonymous Online Contributor

Unverified Answer

Are there any restrictions on who is allowed to enroll in this research project?

"Eligible participants for this study must be able to undergo general anesthesia and be between 18-99 years old. There is a total of 399 slots for this clinical trial." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial restricted to people under the age of 20?

"The age group that this study is targeting is individuals who are over 18 and under 99 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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