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

NCT00990769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-05-31

Study results available
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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.

Conditions

  • Emergence Agitation

Interventions

OTHER

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).

Sponsors & Collaborators

Principal Investigators

  • Heather J Frederick, MD · Duke University

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990769 on ClinicalTrials.gov