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

Evaluation of the Efficacy and Safety of a Combined Dexmedetomidine-Ketamine Sedation Regimen for Pediatric Cardiac Catheterization at Vietnam National Children's Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Catheterization; Pediatric
• Intervention / Treatment: Drug: Spontaneous sedation regimen; Drug: General anesthesia regimen

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Hong Ha Thi Nguyen, PhD; Phone Number: +84904111838; Email: honghant@nch.gov.vn
• Study Contact Backup: Name: Nhat Minh Tran, BPharm, MSc; Phone Number: +84936110303; Email: nhatminh@nch.gov.vn

Study Locations

• Vietnam
  • Hanoi, Vietnam, 10000
    • Recruiting
    • Vietnam National Children's Hospital
    • Contact: Nhat Minh Tran, BPharm, MSc; Phone Number: +84936110303; Email: nhatminh@nch.gov.vn
    • Contact: Hong Ha Thi Nguyen, PhD.; Phone Number: +84904111838; Email: honghant@nch.gov.vn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KETADEX; Pediatric patients undergoing the dexmedetomidine-ketamine spontaneous sedation regimen on cardiac catheterization	Drug: Spontaneous sedation regimen; Patients who are naturally ventilated, undergo spontaneous sedation regimen including: dexmedetomidine and ketamine.
GA; Pediatric patients undergoing the traditional general anesthesia regimen on cardiac catheterization	Drug: General anesthesia regimen; Patients who are mechanically ventilated, undergo general anesthesia regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure	Incidence of respiratory adverse events throughout the cardiac catheterization procedure (sedation/anesthesia induction, cardiac catheterization, and recovery periods) including: Oxygen desaturation: SpO2 decreased > 10% below the lower limit of the normal ranges expressed in percent (%); Respiratory Rate Change: An increase or decrease in respiratory rate by > 20% compared to pre-sedation levels.; Increased Lactate: Lactate level > 2 mmol/L after the procedure (only if lactate level before procedure is ≤ 2 mmol/L), expressed in mmol/L.; Hypercapnia: PaCO2 > 45 mmHg after the procedure (only if PaCO2 level before procedure is ≤ 45 mmHg), expressed in mmHg.; Increased Secretions: Based on clinical observation throughout the procedure, expressed in "yes" or "no".	Perioperative/periprocedural
Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure	Incidence of cardiovascular adverse events throughout the cardiac catheterization procedure (sedation/anesthesia induction, cardiac catheterization, and recovery periods): The presence of bradycardia: Based on age-adjusted criteria, bradycardia was defined as a HR <20% below the lower limit of the normal ranges expressed in beats/min; The presence of tachycardia: Based on age-adjusted criteria, tachycardia was defined as a HR > 20% above the upper limit of the normal ranges expressed in beats/min; The presence of hypertension: Based on age-adjusted criteria hypertension was defined as a MAP >20% above the upper limit of the normal ranges expressed in mmHg; The presence of hypotension: Based on age-adjusted criteria hypertension was defined as a MAP <20% below the lower limit of the normal ranges expressed in mmHg	Perioperative/periprocedural
Incidence of neurological adverse events throughout the recovery period.	Incidence of neurological adverse events during recovery from the procedure: The presence of Nausea and/or Vomiting: defined as the occurrence of nausea and vomitting observed clinically, expressed in "yes" or "no".; The presence of Emergence Agitation and/or Post-Anesthetic Shivering: defined as the occurrence of Emergence Agitation and/or Post-Anesthetic Shivering observed clinically, expressed in "yes" or "no".	Up to 3 hours post-procedural
Incidence of any of the adverse events during the use of the sedation and anesthesia regimen	Any of the respiratory and cardiovascular events during the use of the sedation and anesthesia regimen that are considered not related to pain reaction.	From sedation initiation to the end of the procedure
Incidence of any of the adverse events during the recovery from the procedure	Any of the adverse events during recovery from the procedure.	Up to 3 hours post-procedural

Other Outcome Measures

Outcome Measure	Time Frame
Description of the medications used in the sedation or anesthesia regimen	Perioperative/periprocedural

Collaborators and Investigators

• Sponsor: National Children's Hospital, Vietnam
• Investigators: Principal Investigator: Hong Ha Thi Nguyen, PhD., Vietnam National Children's Hospital

Publications and helpful links

General 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.
• 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

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: general anesthesia; dexmedetomidine; ketamine; cardiac catheterization; spontaneous sedation
• Other Study ID Numbers: 2026S-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No