Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

Study Overview
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Brief Summary
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This study evaluates the association between the depth of general anesthesia and the occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery compared to the deep level of anesthetic depth.

Detailed Description
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EA is characterized by dissociated state of consciousness, in which the children are inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent. Several predisposing factors for EA include post-operative pain, rapid emergence from general anesthesia, use of volatile anesthetics, type and site of operation (usually head & neck surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia. The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population, even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds to the EA identically. In this study, the concentration of anesthetics was not managed on purpose to lower the BIS score. Patients were allocated to each group based on the result of average BIS score during the operation.

Official Title
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The Correlation Between Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

Conditions
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Strabismus

Intervention / Treatment
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* Device: BIS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 3 and 5 years American Society of Anesthesiologists physical status I or II Exclusion Criteria: American Society of Anesthesiologists physical status over III, any disease that could affect mental status pre-existing forehead wound

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low Bispectral index (BIS) group<br>BIS range under 40 | Device: BIS<br>* BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.<br>|
| normal BIS group<br>BIS range from 40 to 60 | Device: BIS<br>* BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Pediatric Anesthesia Emergence Delirium (PAED) Score | Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval. | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthetic depth, emergence agitation