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

Completed · Not applicable

Conditions studied: Emergence Agitation

In brief

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.

Key facts

Study ID

NCT00990769

Run by

Duke University

People needed

40

Starts

2009-09-01

Expected to finish

2010-09-01

Last updated by the study team

2013-05-31

Who can join

Age: 2 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Duke University Medical Center - Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.