Actively Recruiting
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
Led by National Children's Hospital, Vietnam · Updated on 2026-05-04
150
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients under 18 years of age.
- Patients indicated for diagnostic or interventional cardiac catheterization.
You will not qualify if you...
- Patients with acute respiratory infections, chromosomal abnormalities, metabolic disorders, or other co-existing medical conditions.
- Patients with arrhythmias, second- or third-degree atrioventricular block.
- Patients on mechanical ventilation or requiring vasopressors prior to the procedure.
- Known allergy or hypersensitivity to dexmedetomidine, ketamine, propofol, midazolam, or sevoflurane.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vietnam National Children's Hospital
Hanoi, Vietnam, 10000
Actively Recruiting
Research Team
H
Hong Ha Thi Nguyen, PhD
CONTACT
N
Nhat Minh Tran, BPharm, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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