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NCT Number: NCT07564531

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

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.

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Key information

Conditions

Cardiac Catheterization Pediatric

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spontaneous sedation regimen

Drug

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

General anesthesia regimen

Drug

Patients who are mechanically ventilated, undergo general anesthesia regimen

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.

    Time frame: Perioperative/periprocedural

    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.

Secondary outcomes

  1. Incidence of respiratory adverse events throughout the duration of the cardiac catheterization procedure

    Time frame: Perioperative/periprocedural

    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".

  2. Incidence of cardiovascular adverse events throughout the duration of the cardiac catheterization procedure

    Time frame: Perioperative/periprocedural

    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

  3. Incidence of neurological adverse events throughout the recovery period.

    Time frame: Up to 3 hours post-procedural

    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".

  4. 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

    Any of the respiratory and cardiovascular events during the use of the sedation and anesthesia regimen that are considered not related to pain reaction.

  5. Incidence of any of the adverse events during the recovery from the procedure

    Time frame: Up to 3 hours post-procedural

    Any of the adverse events during recovery from the procedure.

Other outcomes

  1. Description of the medications used in the sedation or anesthesia regimen

    Time frame: Perioperative/periprocedural

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Ha Thi Nguyen, PhD

CONTACT

[email protected]

+84904111838

Nhat Minh Tran, BPharm, MSc

CONTACT

[email protected]

+84936110303

Sponsors and collaborators

Lead sponsor

National Children's Hospital, Vietnam

Other

Registry information

Official study title

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

Acronym: KETADEX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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