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

Recruiting now · Phase 1

Conditions studied: Sedation and Analgesia

In brief

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

Key facts

Study ID

NCT07669012

Run by

Ain Shams University

People needed

124

Starts

2025-10-22

Expected to finish

2027-02-15

Last updated by the study team

2026-06-25

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ain shams university hospital — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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