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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

RecruitingPhase 1Ages 2 Years - 12 YearsAllAin Shams University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 2-12 years, male or female * Weight โ‰ฅ 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
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What it tests

  • Ketamine + propofol
  • Dexmedetomidine + propofol
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Where

1 site
Ain shams university hospital
Cairo, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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