The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

Study Overview
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Brief Summary
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The purpose of this study is to determine whether depth of anesthesia has an effect on emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of anesthesia on EA has not been studied. The study will randomize 40 children undergoing ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.

Official Title
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The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

Conditions
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Emergence Agitation

Intervention / Treatment
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* Other: Depth of anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery American Society of Anesthesiology (ASA) physical status 1 or 2 Exclusion Criteria: Surgery precluding placement of BIS monitor Non-English speaking, until additional language consent forms are approved Previous history of severe emergence agitation

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-normal BIS (Lighter anesthesia)<br>Depth of anesthesia is titrated to a BIS of 55-60 | Other: Depth of anesthesia<br>* The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).<br>|
| Experimental: Low-normal BIS (Deeper anesthesia)<br>Depth of anesthesia is maintained at a BIS level of 40-45 | Other: Depth of anesthesia<br>* The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) | The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation. | Within 30 minutes of arrival in recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Emergence From Anesthesia | The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation. | After the completion of surgery | 
| Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) | Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study. | Within 30 minutes of arrival in recovery room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depth of anesthesia, Emergence delirium, Bispectral Index