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The occurrence of emergence agitation (EA) in pediatric patients who have received sevoflurane anesthesia is a common postoperative problem. Among various strategies for reducing the incidence and severity of EA, the use of pharmacological agents at the end of anesthesia is thought to be the most convenient and easily applicable method in clinical situation. The one of typical agents that can be administered in this way is propofol. Previous studies demonstrated that the use of propofol 1mg/kg at the end of anesthesia could reduce the incidence of EA with low incidence of postoperative nausea and vomiting. However, it was also demonstrated that the use of propofol 1mg/kg at the end of anesthesia could delay the emergence time. The purpose of this study is to compare the preventive effect on EA and the emergence time between propofol 1mg/kg and propofol 0.5mg/kg administered at the end of sevoflurane anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1) propofol 1.0mg/kg group | Experimental | According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery |
|
| 2) propofol 0.5mg/kg group | Experimental | According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery |
|
| 3) normal saline group | Placebo Comparator | According to randomly allocated group, propofol 1.0mg/kg, propofol 0.5mg/kg or normal saline will be intravenously administered at the end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of propofol 1.0mg/kg | Drug |
| ||
| propofol 0.5mg/kg |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of the emergence agitation | from extubation up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| the emergence time | The emergence time was defined as the time from discontinuation of sevoflurane to extubation. | within the first 1hour after end of strabismus surgery |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with developmental disability, mental retardation, neurologic disorder, ongoing neurologic medication such as anticonvulsant, previously undergoing general anesthesia, a recent history of upper respiratory infection, parents difficult to read or understand the informed consent.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Soo KIM, MD | Contact | 02-2019-3522 | kmsviola@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital, Yonsei University College of Medicine | Recruiting | Seoul | Seoul | 135-720 | South Korea |
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| Drug |
|
| normal saline | Drug |
|
| ID | Term |
|---|---|
| D013285 | Strabismus |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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