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

NCT07564531 | Recruiting

• 1 other identifier: 2026S-07
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Catheterization; Pediatric

Keywords

dexmedetomidine; ketamine; spontaneous sedation; general anesthesia; cardiac catheterization

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary endpoint is the rate of achieving the sedation target, which is Ramsay Sedation Scale score of 6, without the need for rescue anesthesia and without any adverse events in cardiovascular, respiratory, or neurological systems occurred during the anesthesia/sedation induction, cardiac catheterization, and recovery periods.

  Perioperative/periprocedural

Secondary Outcomes (5)

• Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure

  Perioperative/periprocedural

• Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure

  Perioperative/periprocedural

• Incidence of neurological adverse events throughout the recovery period.

  Up to 3 hours post-procedural

• Incidence of any of the adverse events during the use of the sedation and anesthesia regimen

  From sedation initiation to the end of the procedure

• Incidence of any of the adverse events during the recovery from the procedure

  Up to 3 hours post-procedural

Other Outcomes (1)

• Description of the medications used in the sedation or anesthesia regimen

  Perioperative/periprocedural

Study Arms (2)

KETADEX

Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization

Drug: Spontaneous sedation regimen

GA

Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization

Drug: General anesthesia regimen

Interventions

Spontaneous sedation regimen DRUG

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

KETADEX

General anesthesia regimen DRUG

Patients who are mechanically ventilated, undergo general anesthesia regimen

GA

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing cardiac catheterization at Vietnam National Children's Hospital

You may qualify if:

• Patients under 18 years of age.
• Patients indicated for diagnostic or interventional cardiac catheterization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Children's Hospital, Vietnam: lead

Study Sites (1)

Vietnam National Children's Hospital

Hanoi, 10000, Vietnam

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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.v65iCD9.1506

  BACKGROUND

Related Links

• Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy
• Dexmedetomidine Sedation in Children With Respiratory Morbidities

Study Officials

• Hong Ha Thi Nguyen, PhD.

  Vietnam National Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Ha Thi Nguyen, PhD

CONTACT

+84904111838; honghant@nch.gov.vn

Nhat Minh Tran, BPharm, MSc

CONTACT

+84936110303; nhatminh@nch.gov.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pharmacy Department

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: May 4, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

VN (1)