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The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:
• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?
Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Propofol group | Active Comparator | children will be randomized to receive propofol 1mg/kg over 10 minutes |
|
| Group 2: Dexmedetomidine group | Active Comparator | children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive propofol 1mg/kg over 10 minutes (group 1) . |
| Measure | Description | Time Frame |
|---|---|---|
| the overall incidence of postoperative Emergence Agitation | Pediatric Anesthesia Emergence Delirium (PAED) scale will be use to assess the incidence of Emergence Agitation (EA) A PAED score of 10 or higher is considered to be diagnostic of EA, but a score of 12 or higher is more sensitive and specific. | EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3). |
| Measure | Description | Time Frame |
|---|---|---|
| heart rate changes | heart rate (HR) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU. | 30 minutes in the PACU |
| mean arterial pressure (MAP) changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Cairo Governorate | 11517 | Egypt |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Dexmedetomidine | Drug | After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes (group 2). |
|
|
mean arterial pressure (MAP) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.
| 30 minutes in the PACU |
| peripheral oxygen saturation (SpO2) changes | peripheral oxygen saturation (SpO2) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU. | 30 minutes in the PACU |
| Proportion of patients with adverse events in the PACU | including oxygen desaturation defined as SpO2 < 90%, regarded as severe desaturation when SpO2 < 85%, bradycardia defined as HR < 80 beats/min , shivering, dizziness, laryngospasm, severe coughing, and reintubation. | assessed up to 30 minutes after arrival of patient to PACU. |
| Proportion of patients with Post Operative Nausea and Vomiting (PONV) | evaluated by a 4-point PONV Scale . | assessed up to 30 minutes after arrival of patient to PACU. |
| Time to discharge from the PACU. | the time the patients needs to be stable and discharge from the PACU | 60 minutes |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |