The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

Study Overview
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Brief Summary
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The present tiral conduted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incedence of emergence agitation (EA) comparing to neostigmine

Detailed Description
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EA is one of the most common postoperative complications in after general anesthesia in pre-school aged pediatric patients. There are several causes contributed to occurrence of EA such as postoperative pain, type of surgery and surgical site, hyperthermia or hypothermia. Some researches showed that the occurrence of EA is associated with patients' anxiety and we inferred that patients' anxiety after general anesthesia could be related to ability to breathe. Ability to breathe is highly associated with level of residual neuromuscular blockade (NMB) after recovery from general anesthesia. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether sugammadex as reversal agents of NMB reduces the incidence of EA in pediatric patients who undergo strabismus surgery.

Official Title
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The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial

Conditions
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Emergence Delirium, Strabismus, Pediatric ALL

Intervention / Treatment
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* Drug: Bridion 200 MG in 2 ML Injection
* Drug: Neostigmine Methylsulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pateints scheduled elective stramismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3. Exclusion Criteria: ASA classification 3 or more impaired liver function impaired kidney function myasthenia gravis or other neuromuscular disorders history of drug allergy cardiovascular disease or arryrhthmia

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group neostigmine<br>If TOF count is 1 or less, wait until it becomes 2 and then give the patient neostigmine dose of 50mcg/kg. If TOF count shows 4 with fade, 40mcg/kg of neostigmine is administered and without fade, 20mcg/kg is administered. | Drug: Neostigmine Methylsulfate<br>* Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.<br>* Other names: neostigmine;|
| Active Comparator: group sugammadex<br>If TOF count shows 0 and PTC (posttetanic count) is 1 or more, sugamadex administered dose of 4mg/kg. If TOF count shows 1 or more, 2mg/kg is administered. | Drug: Bridion 200 MG in 2 ML Injection<br>* Sugammadex and neostigmine are administered at the end of surgery after assessment of the level of neuromuscular blockade is done. The dosage of each revesal agent is determined with response to TOF or PTC.<br>* Other names: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of EA in postanesthesia care unit (PACU) | EA is assessed with the PAED scale in PACU. EA is defined as the score is 10 or higher. | EA is assessed three times at 15-min intervals from the end of anesthesia to dischrage from PACU. |