RecruitingNCT07564531

Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization

Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital


Sponsor

National Children's Hospital, Vietnam

Enrollment

150 participants

Start Date

Feb 4, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn if the spontaneous sedation regimen of dexmedetomidine-ketamine (KETADEX) has the comparable efficacy and safety in pediatric cardiac catheterization versus the traditional regimen. The main question it aims to answer is: Is the combined Dexmedetomidine-Ketamine spontaneous sedation regimen (KETADEX) non-inferior to the traditional general anesthesia regimen in terms of efficacy and safety? Participants would received either KETADEX regimen or general anesthesia regimen. Research members then observe the catheterization procedure and answer the questionnaire about their efficacy and safety.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called General anesthesia regimen and a drug called Spontaneous sedation regimen for people with cardiac catheterization and pediatric. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSpontaneous sedation regimen

Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.

DRUGGeneral anesthesia regimen

Patients who are mechanically ventilated, undergo general anesthesia regimen


Locations(1)

Vietnam National Children's Hospital

Hanoi, Vietnam

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NCT07564531


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