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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group KP: Ketamine + Propofol. | Active Comparator | Group that will receive Propofol and ketamine |
|
| Group DP: Dexmedetomidine + Propofol | Active Comparator | Group that will receive Dexmedetomidine and Propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine + propofol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Heart Rate | Heart rate (bpm) measured during the procedure and recovery period. | 2 hours |
| Mean Arterial Pressure | Mean arterial pressure ( mmHg) measured during the procedure and recovery period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university hospital | Recruiting | Cairo | Egypt |
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| Dexmedetomidine + propofol | Drug | 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 |
|
|
| 2 hours |
| Recovery time | Time from discontinuation of sedative administration to achievement of discharge readiness based on the institution's recovery criteria. | 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. | 2 hours |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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