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Recruiting NCT07564531

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

— Observational Cardiac Catheterization Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spontaneous sedation regimen, General anesthesia regimen.
Who it may be relevant to
Registry conditions: Cardiac Catheterization, Pediatric. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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

Primary outcome measures

  • The rate of achieving Ramsay Sedation Scale score 6 without the need for rescue anesthesia and the occurrence of any adverse events throughout the duration of the cardiac catheterization procedure. [Time frame: Perioperative/periprocedural]
Secondary outcome measures (5)
  • Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure [Time frame: Perioperative/periprocedural]
  • Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure [Time frame: Perioperative/periprocedural]
  • Incidence of neurological adverse events throughout the recovery period. [Time frame: Up to 3 hours post-procedural]
  • Incidence of any of the adverse events during the use of the sedation and anesthesia regimen [Time frame: From sedation initiation to the end of the procedure]
  • Incidence of any of the adverse events during the recovery from the procedure [Time frame: Up to 3 hours post-procedural]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Vietnam · 1 center
  • Vietnam National Children's Hospital — Hanoi

Publications

  • Mikus M, Welchowski T, Schindler E, Schneider M, Mini N, Vergnat M. Sedation versus General Anesthesia for Cardiac Catheterization in Infants: A Retrospective, Monocentric, Cohort Evaluation. J Clin Med. 2021 Nov 30;10(23):5648. doi: 10.3390/jcm10235648. PMID 34884350
  • Hằng, N. T. T., Nam, Đỗ V., Hà, N. T. N., Minh, Đỗ T., Trang, H. T. T., Anh, N. T. V., Huệ, V. T. ., Anh, N. N., Phúc, N. X., & Tuyên, H. N. (2024). 1. KẾT HỢP DEXMEDETOMIDINE VÀ KETAMIN ĐỂ AN THẦN TỰ THỞ CHO BỆNH NHÂN NHI ĐANG THỰC HIỆN THÔNG TIM: KẾT QUẢ BAN ĐẦU TẠI BỆNH VIỆN NHI TRUNG ƯƠNG VIỆT NAM. Tạp Chí Y học Cộng đồng, 65(CĐ 9 - Hội Gây mê Hồi sức). https://doi.org/10.52163/yhc.v65iCD9.150

Identifiers

NCT: NCT07564531 · 2026S-07

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗