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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

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.

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Detailed Description

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Conditions

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Emergence Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High-normal BIS ("Lighter" anesthesia)

Depth of anesthesia is titrated to a BIS of 55-60

Group Type EXPERIMENTAL

Depth of anesthesia

Intervention Type OTHER

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).

Low-normal BIS ("Deeper" anesthesia)

Depth of anesthesia is maintained at a BIS level of 40-45

Group Type EXPERIMENTAL

Depth of anesthesia

Intervention Type OTHER

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).

Interventions

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Depth of anesthesia

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).

Intervention Type OTHER

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No