A Phase 1 interventional study of Ketamine + propofol and Dexmedetomidine + propofol in Sedation and Analgesia, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Ain Shams University · Phase 1, Interventional, and Treatment
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
1,189 studies on the registry are indexed under Agnosia; 507 are open to participants now.
This study's planned enrollment of 124 is above the median of 77 across 1,023 interventional studies indexed under Agnosia.
Browse Agnosia studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group that will receive Propofol and ketamine
Drug: Ketamine + propofol
Group that will receive Dexmedetomidine and Propofol
Drug: Dexmedetomidine + propofol
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
Also known as: 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
Also known as: Sedation
Incidence 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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Ain Shams University