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
National Children's Hospital, Vietnam
150 participants
Feb 4, 2026
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
Inclusion Criteria2
- Patients under 18 years of age.
- Patients indicated for diagnostic or interventional cardiac catheterization.
Exclusion Criteria3
- 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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Interventions
Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
Patients who are mechanically ventilated, undergo general anesthesia regimen
Locations(1)
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NCT07564531