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
Ain Shams University
124 participants
Oct 22, 2025
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria9
- 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 Criteria22
- 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
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Interventions
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07669012