Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization
Sponsor: National Children's Hospital, Vietnam
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.
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
Key Details
Gender
All
Age Range
Any - 18 Years
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-02-04
Completion Date
2026-12-30
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
Interventions
Spontaneous sedation regimen
Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
General anesthesia regimen
Patients who are mechanically ventilated, undergo general anesthesia regimen
Locations (1)
Vietnam National Children's Hospital
Hanoi, Vietnam