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

NCT07564531 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Cardiac Catheterization
  • Pediatric

Interventions

DRUG

Spontaneous sedation regimen

Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.

DRUG

General anesthesia regimen

Patients who are mechanically ventilated, undergo general anesthesia regimen

Sponsors & Collaborators

  • National Children's Hospital, Vietnam

    lead OTHER

Principal Investigators

  • Hong Ha Thi Nguyen, PhD. · Vietnam National Children's Hospital

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07564531 on ClinicalTrials.gov