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HSK3486 vs Propofol for General Anesthesia

Phase 3

Recruiting

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

Study Summary

This trialfound HSK3486 and Propofol to be equally effective for general anesthesia in adults having surgery.

Who is the study for?

Adults aged 18+ needing elective surgery with general anesthesia can join. They must be in stable health (ASA-PS I to IV), not pregnant, and agree to use birth control. Excluded are those with recent heart attacks, uncontrolled conditions, severe allergies, or drug abuse.Check my eligibility

What is being tested?

The trial is testing HSK3486 against Propofol for inducing anesthesia in adults before surgery. Participants will receive an initial dose followed by an additional dose if needed to see if HSK3486 is as effective as Propofol.See study design

What are the potential side effects?

Possible side effects of both HSK3486 and Propofol include pain at the injection site, dizziness, nausea, headache, or low blood pressure. Severe reactions could involve breathing difficulties or allergic responses.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes from end of drug administration for reporting.

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 • NCT04711837

28%

Hypotension

27%

Nausea

19%

Procedural Pain

100%

80%

60%

40%

20%

Study treatment Arm

HSK3486

Propofol

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HSK3486 for general anesthesia inductionExperimental Treatment1 Intervention

HSK3486 for induction of general anesthesia

Group II: Propofol for general anesthesia inductionActive Control1 Intervention

Propofol for induction of general anesthesia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HSK3486

2019

Completed Phase 3

~1630

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Haisco-USA Pharmaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

698 Total Patients Enrolled

2 Trials studying General Anesthesia

443 Patients Enrolled for General Anesthesia

Media Library

HSK3486 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05486416 — Phase 3

General Anesthesia Research Study Groups: HSK3486 for general anesthesia induction, Propofol for general anesthesia induction

General Anesthesia Clinical Trial 2023: HSK3486 Highlights & Side Effects. Trial Name: NCT05486416 — Phase 3

HSK3486 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05486416 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell us the level of risk associated with HSK3486 for general anesthesia patients?

"There is both efficacy and safety data from Phase 3 clinical trials, so our team at Power has given HSK3486 a score of 3 for general anesthesia induction."

Answered by AI

Are people currently being signed up for this clinical trial?

"The clinical trial reported on clinicaltrials.gov is no longer recruiting patients. The original posting was on October 26th, 2023 and the most recent update was on November 9th, 2022. There are 23 other trials that are still open to participants."

Answered by AI

Are there many study locations within North America for this clinical trial?

"There are six locations where this clinical trial is being conducted. These include UPMC - Presbyterian/Montefiore in Pittsburgh, Brigham & Women's Hospital in Boston, and UPMC - Shadyside Hospital in Salt Lake City among others."

Answered by AI

Is this trial open to patients who are over 35 years of age?

"Based on the eligibility requirements for this clinical trial, adults aged 18 to 99 are able to participate."

Answered by AI

Who meets the screening requirements for this research project?

"This clinical trial is recruiting 399 patients aged 18-99 who will be undergoing general anesthesia. In order to participate, patients must also meet the following criteria: 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 ("

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery

2024. "Safety and Efficacy of HSK3486 Compared to Propofol for Induction of General Anesthesia in Adults With Elective Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05486416.

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