NCT07669012RecruitingPhase 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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 124
- Locations
- 1
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts 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
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Comparison of dexmedetomidine alone vs Dexmedetomidine combined with Ketamine for better blood pressure stability and pain control during spine surgery under general anaesthesiaCTRI/2026/02/103816Heritage Institute of Medical Sciences84
Not yet recruiting
Phase 3
A study comparing two different combinations for giving anaesthesia in short surgeriesCTRI/2025/08/093390Vinayaka Missions Kirupananda Variyar Medical College and Hospitals Chinnaseeragapadi Salem60
Not yet recruiting
Not Applicable
Comparison Between Two Drugs in Sedation of Upper GI EndoscopyNCT07423676Zagazig University52
Recruiting
Phase 2
The Effect of Dormicum-Ketamine Versus Dexmedetomidine on Emergence Delirium During Deep Sedation in Paediatric Burn PatientsEmergence Delirium in Pediatric AnesthesiaNCT07519863Ain Shams University60
Not yet recruiting
Not Applicable
A study comparing how well a mixture of ketamine and propofol works versus propofol alone for inducing anaesthesia prior to ENT surgery using brain activity monitoring called bispectral index monitoring.CTRI/2025/08/092237Kalinga Institute of Medical Sciences, Bhubaneswar112