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NCT Number: NCT07669012

a Comparive Study of Ketamine-Propofol Versus Dexmedetomidine-Propofol Sedation in Pediatric Patients Undergoing Cardiac Catheterization for Device Closure of Simple Left-to-right Shunts

This study aims To compare the safety and efficacy of ketamine-propofol versus dexmedetomidine-propofol sedation in pediatric patients undergoing cardiac catheterization for device closure of simple left-to-right shunts

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Key information

Conditions

Sedation and Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain shams university hospital

Cairo, Egypt

Location status: Recruiting

Location contact

Noha Tarek Hassan

CONTACT

[email protected]

01000667030

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 2-12 years, male or female
  • Weight ≥ 10 kg
  • Scheduled for elective transcatheter device closure of a simple left-to-right shunt, including:
  • Secundum atrial septal defect (ASD) suitable for device closure
  • Small muscular ventricular septal defect (VSD) eligible for percutaneous device closure
  • Patent ductus arteriosus (PDA) closure
  • Procedure performed with transthoracic or transesophageal echocardiographic guidance according to the cardiology team's practice
  • ASA physical status II-III
  • Written informed consent obtained from a parent or legal guardian

Exclusion criteria

  • Cyanotic congenital heart disease
  • Complex congenital cardiac lesions
  • Risk of pulmonary hypertensive crisis
  • Requirement for general anesthesia and cuffed endotracheal tube at the discretion of the cardiology or anesthesia team
  • Baseline oxygen requirement > 2 L/min
  • Use of noninvasive ventilation
  • Known allergy or intolerance to ketamine, dexmedetomidine, or propofol
  • Significant hepatic impairment
  • Significant renal impairment
  • Advanced atrioventricular block
  • Clinically significant bradyarrhythmia
  • Uncontrolled epilepsy
  • Raised intracranial pressure
  • Severe obstructive sleep apnea
  • Craniofacial anomalies associated with anticipated difficult airway management
  • BMI > 97th percentile when judged to confer high risk of sedation-related airway obstruction
  • Current beta-blocker use
  • Current clonidine use
  • Acute upper respiratory tract infection within 2 weeks before the procedure
  • Emergency or add-on procedures
  • Anticipated procedure duration < 20 minutes
  • Anticipated procedure duration > 3 hours

Treatment and study plan

Ketamine + propofol

Drug

Ketamine IV bolus 1 mg/kg (range commonly 0.5-1.5 mg/kg) administered as an initial bolus to provide analgesia and hemodynamic support; followed by a propofol infusion 100-150 µg/kg/min (titrated to clinical effect).

Rescue propofol boluses 0.5 mg/kg IV may be given for inadequate sedation

Other names: Sedation

Dexmedetomidine + propofol

Drug

Dexmedetomidine loading dose 1 µg/kg over 10 minutes (range 0.5-1 µg/kg reported) followed by maintenance infusion per clinical need; co-administration of propofol infusion 100-150 µg/kg/min, titrated to the sedation target.

Rescue propofol boluses 0.5 mg/kg IV may be used for breakthrough movement or inadequate sedation

Other names: Sedation

Primary outcomes

  1. Incidence of respiratory complications

    Time frame: 2 hours

    Percentage of participants experiencing one or more respiratory complications (apnea, hypoxemia, atelectasis, hypercapnia, or need for advanced airway management) during the study period.

Secondary outcomes

  1. Mean Heart Rate

    Time frame: 2 hours

    Heart rate (bpm) measured during the procedure and recovery period.

  2. Mean Arterial Pressure

    Time frame: 2 hours

    Mean arterial pressure ( mmHg) measured during the procedure and recovery period.

  3. Recovery time

    Time frame: 2 hours

    Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria.

  4. Adequate Sedation rate

    Time frame: 2 hours

    Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 25, 2026
Registry last updated
Jun 25, 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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