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The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.
Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose remifentanil group | Experimental | Intervention: high dose remifentanil will be administrated. |
|
| low dose remifentanil group | Experimental | Intervention: low dose remifentanil will be administrated |
|
| No remifentanil group | Placebo Comparator | Intervention: no remifenatnil will be administrated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose remifentanil | Drug | Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative vomiting in PACU and surgical ward | Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups. | from extubation to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain in PACU and surgical ward | Postoperative pain will be assessed using Faces Pain Rating Scale. | from extubation to 24 hours |
| postoperative emergence agitation | Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee, M.D. | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haeundae paik hospital, inje university | Busan | 612-896 | South Korea |
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| ID | Term |
|---|---|
| D013285 | Strabismus |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| C023768 | halofantrine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Low dose remifentanil | Drug | Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes |
|
|
| No remifentanil | Drug | Intervention: no remifentanil will be administrated |
|
|
| from extubation to 24 hours |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |