NCT07564531 Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
| NCT ID | NCT07564531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Children's Hospital, Vietnam |
| Condition | Cardiac Catheterization |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-02-04 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Hong Ha Thi Nguyen, PhD.
PRINCIPAL INVESTIGATOR
National Children's Hospital, Vietnam
Frequently Asked Questions
Who can join the NCT07564531 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Cardiac Catheterization. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564531 currently recruiting?
Yes, NCT07564531 is actively recruiting participants. Contact the research team at honghant@nch.gov.vn for enrollment information.
Where is the NCT07564531 trial being conducted?
This trial is being conducted at Hanoi, Vietnam.
Who is sponsoring the NCT07564531 clinical trial?
NCT07564531 is sponsored by National Children's Hospital, Vietnam. The principal investigator is Hong Ha Thi Nguyen, PhD. at National Children's Hospital, Vietnam. The trial plans to enroll 150 participants.