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

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

Sponsors

Lead sponsor: Duke University

Source Duke University
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.

Overall Status Completed
Start Date September 2009
Completion Date September 2010
Primary Completion Date September 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit) Within 30 minutes of arrival in recovery room
Secondary Outcome
Measure Time Frame
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
Enrollment 40
Condition
Intervention

Intervention type: Other

Intervention name: Depth of anesthesia

Description: 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).

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

Gender: All

Minimum age: 2 Years

Maximum age: 8 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Heather J Frederick, MD Principal Investigator Duke University
Location
facility
Duke University Medical Center - Eye Center
Location Countries

United States

Verification Date

May 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Duke University

Investigator full name: Heather Frederick

Investigator title: Dr. Heather Frederick

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: High-normal BIS ("Lighter" anesthesia)

Arm group type: Experimental

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

Arm group label: Low-normal BIS ("Deeper" anesthesia)

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov