The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emergence Agitation
- Sponsor
- Duke University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Heather Frederick
Dr. Heather Frederick
Duke University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)
Time Frame: Within 30 minutes of arrival in recovery room
The PAED scale is a validated observational measure of five aspects of child behavior on emergence from anesthesia (caregiver eye contact, purposeful movement, evidence of awareness of surroundings, restlessness, and inconsolability). Ratings are summed to arrive at a total score ranging from 0 - 20, with higher scores indicating greater severity of emergence agitation.
Secondary Outcomes
- Time to Emergence From Anesthesia(After the completion of surgery)
- Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC)(Within 30 minutes of arrival in recovery room)