Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorNational Children's Hospital, Vietnam

About this trial

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

Qualifiers

Patients under 18 years of age.

Patients indicated for diagnostic or interventional cardiac catheterization.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Spontaneous sedation regimen
  • General anesthesia regimen

Treatment groups

150 Participants
are divided into 2 treatment groups