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
Phase 1Interventional Study
Sedation and Analgesia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
2 – 12
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
124 (estimated)
Sponsor
Ain Shams University · Other
Who this trial is looking for
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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
Trial Locations
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Eligibility Criteria
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 per…
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
Contacts
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