Dexmedetomidine–Ketamine (KETADEX) versus General Anesthesia for Sedation in Children Having Cardiac Catheterization
Official title: Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital
Run by National Children's Hospital, Vietnam · NCT07564531 · Data updated 2026-11-12
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 |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | National Children's Hospital, Vietnam Academic / other |
| Locations | 1 site (Hanoi) |
| Status | Recruiting |
| Started | February 4, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT07564531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Vietnam National Children's Hospital
Hanoi, Vietnam Recruiting
Study contacts
- Principal investigator: Hong Ha Thi Nguyen, PhD. — National Children's Hospital, Vietnam
- Study coordinator: Hong Ha Thi Nguyen, PhD
- Email: honghant@nch.gov.vn
- Phone: +84904111838
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.