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

NCT00990769 | Completed Results

• 1 other identifier: Pro00015531
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Keywords

Emergence delirium; Bispectral Index; Depth of anesthesia

Outcome Measures

Primary Outcomes (1)

• Peak Pediatric Assessment of Emergence Delirium (PAED) Score Within the First 30 Minutes of Reaching the Recovery Room (Post-Anesthesia Care Unit)

  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.

  Within 30 minutes of arrival in recovery room

Secondary Outcomes (2)

• 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

Study Arms (2)

High-normal BIS ("Lighter" anesthesia)

EXPERIMENTAL

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

Other: Depth of anesthesia

Low-normal BIS ("Deeper" anesthesia)

EXPERIMENTAL

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

Other: Depth of anesthesia

Interventions

Depth of anesthesia OTHER

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).

High-normal BIS ("Lighter" anesthesia); Low-normal BIS ("Deeper" anesthesia)

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center - Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Heather Frederick
• Organization: Duke University Medical Center

heather.frederick@duke.edu

919-812-6204

Study Officials

• Heather J Frederick, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Heather Frederick

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 7, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-05

Locations

US (1)