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The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.
Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| remifentanil group | Experimental | Remifentanil 0.05 ug/kg/min is infused to the patients. |
|
| control | Placebo Comparator | Normal saline 0.2 ml/kg/hour is infused to the patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| the scale of emergence agitation | A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit. | up to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| the effect of remifentanil on the emergence | A blinded observer record duration of anaesthesia, eye-opening time, time to remove laryngeal mask airway, respiratory depression, nausea, and vomiting at the end of surgery, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangjin Park, M.D. | Contact | 82-53-620-3366 | apsj0718@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Sangjin Park, M.D. | Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Yeungnam University hospital | Recruiting | Daegu | 705-035 | South Korea |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug |
|
| up to 30 minutes after the discharge form postanesthetic care unit |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |