Dexmedetomidine–Ketamine (KETADEX) versus General Anesthesia for Sedation in Children Having 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
This project will test whether a combined dexmedetomidine‑ketamine (KETADEX) sedation works as well and is as safe as general anesthesia for children undergoing cardiac catheterization.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | National Children's Hospital, Vietnam Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT07564531 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of a spontaneous sedation regimen combining dexmedetomidine and ketamine (KETADEX) versus the traditional general anesthesia approach in pediatric cardiac catheterization. Children under 18 scheduled for diagnostic or interventional catheterization receive either the KETADEX regimen or general anesthesia as part of routine care, and researchers observe the procedures and collect safety and efficacy information. Outcomes are recorded through direct observation and standardized questionnaires filled out by research staff. The main goal is to determine if KETADEX is non‑inferior to general anesthesia with respect to procedure success and safety events.
Who should consider this trial
Good fit: Children under 18 years old who are scheduled for diagnostic or interventional cardiac catheterization and do not have the listed exclusion conditions are eligible.
Not a fit: Patients with acute respiratory infections, significant arrhythmias or AV block, those on mechanical ventilation or vasopressors before the procedure, or with known allergies to the study drugs are unlikely to benefit from the KETADEX approach.
Why it matters
Potential benefit: If successful, KETADEX could allow some children to avoid general anesthesia, potentially speeding recovery and reducing anesthesia‑related risks.
How similar studies have performed: Previous reports and small studies have shown promising safety and effectiveness for dexmedetomidine plus ketamine in pediatric procedural sedation, but direct observational comparisons with general anesthesia in cardiac catheterization are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hanoi
- Vietnam National Children's Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Hong Ha Thi Nguyen, PhD. — Vietnam National Children's Hospital
- Study coordinator: Hong Ha Thi Nguyen, PhD
- Email: honghant@nch.gov.vn
- Phone: +84904111838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.