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

Recruitingn/aAges any - 18 YearsAllNational Children's Hospital, Vietnam
NCT07564531 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients under 18 years of age. * Patients indicated for diagnostic or interventional cardiac catheterization. Exclusion Criteria: * Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions. * Arrhythmias, second- or third-degree atrioventricular (AV) block; patients on mechanical ventilation or requiring vasopressors prior to the procedure. * Known history of allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.
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What it tests

  • Spontaneous sedation regimen
  • General anesthesia regimen
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Where

1 site
Vietnam National Children's Hospital
Hanoi, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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