Sedation and Analgesia
Conditions
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
Interventions
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 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heart Rate | 2 hours | Heart rate (bpm) measured during the procedure and recovery period. |
| Mean Arterial Pressure | 2 hours | Mean arterial pressure ( mmHg) measured during the procedure and recovery period. |
| Recovery time | 2 hours | Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria. |
| Adequate Sedation rate | 2 hours | Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen. |
Countries
Egypt
Outcome results
None listed