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

Duke University

Status: Completed

Conditions: Emergence Agitation

Treatments: Other: Depth of anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00990769

Pro00015531

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

High-normal BIS ("Lighter" anesthesia)

Experimental group

Description:

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

Treatment:

Other: Depth of anesthesia

Low-normal BIS ("Deeper" anesthesia)

Experimental group

Description:

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

Treatment:

Other: Depth of anesthesia