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Recruiting Phase 1

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

NCT07669012 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1
Started
2025-10-22
Last updated
2026-06-25

Condition(s) studied

Sedation and Analgesia

Investigational drug(s) / intervention(s)

Ketamine + propofolAll Ketamine trials (43) →All Propofol trials (79) →Dexmedetomidine + propofolAll Dexmedetomidine trials (145) →All Propofol trials (79) →

Ketamine + propofol: 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 + propofol: 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

Study 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

Sex
ALL
Min age
2 Years
Max age
12 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of respiratory complications — 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.

Trial sites (1)

FacilityCityRegionStatus
Ain shams university hospital Cairo Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07669012 on ClinicalTrials.gov ↗ ← All trials in Egypt