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

Not Applicable

Completed

• Conditions: Emergence Agitation
• Interventions: Other: Depth of anesthesia

• Registration Number: NCT00990769
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2013-04-10
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Results First Posted: 2013-05-31
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children age 2 - 8 (inclusive) undergoing ophthalmologic surgery
• American Society of Anesthesiology (ASA) physical status 1 or 2

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Exclusion Criteria

• Surgery precluding placement of BIS monitor
• Non-English speaking, until additional language consent forms are approved
• Previous history of severe emergence agitation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-normal BIS ("Lighter" anesthesia)	Depth of anesthesia	Depth of anesthesia is titrated to a BIS of 55-60
Low-normal BIS ("Deeper" anesthesia)	Depth of anesthesia	Depth of anesthesia is maintained at a BIS level of 40-45

Primary Outcome Measures

Name	Time	Method
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)	Within 30 minutes of arrival in recovery room	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.

Secondary Outcome Measures

Name	Time	Method
Time to Emergence From Anesthesia	After the completion of surgery	The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.
Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)	Within 30 minutes of arrival in recovery room	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.

Trial Locations

Locations (1)

Duke University Medical Center - Eye Center; 🇺🇸 Durham, North Carolina, United States