NCT00990769

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-10-07
• Last updated: 2013-05-31
• Results posted: 2013-05-31

Locations

1 site across 1 country: United States