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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
124
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
Ain shams university hospital
Cairo, Egypt
RECRUITINGIncidence of respiratory complications
Percentage of participants experiencing one or more respiratory complications (apnea, hypoxemia, atelectasis, hypercapnia, or need for advanced airway management) during the study period.
Time frame: 2 hours
Mean Heart Rate
Heart rate (bpm) measured during the procedure and recovery period.
Time frame: 2 hours
Mean Arterial Pressure
Mean arterial pressure ( mmHg) measured during the procedure and recovery period.
Time frame: 2 hours
Recovery time
Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria.
Time frame: 2 hours
Adequate Sedation rate
Percentage of participants achieving the target level of sedation throughout the procedure without requiring a change in the assigned sedation regimen.
Time frame: 2 hours
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