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

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ClinicalTrials.gov Identifier: NCT00990769
Recruitment Status : Completed
First Posted : October 7, 2009
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Heather Frederick, Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Emergence Agitation Other: Depth of anesthesia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Delirium

Arms and Interventions
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Arm Intervention/treatment
Experimental: High-normal BIS ("Lighter" anesthesia)
Depth of anesthesia is titrated to a BIS of 55-60
 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).
Experimental: Low-normal BIS ("Deeper" anesthesia)
Depth of anesthesia is maintained at a BIS level of 40-45
 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to Emergence From Anesthesia [ Time Frame: After the completion of surgery ]
    The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.

  2. Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) [ Time Frame: Within 30 minutes of arrival in recovery room ]
    Pain was assessed with the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale. The FLACC scale is an observational measure of child behavior in response to postoperative pain. Five subscales are rated from 0-2 on severity: facial expression, leg position and motion, psychomotor agitation, crying, and inconsolability. Subscale scores are summed to compute a total score ranging from 0-10, with 10 representing the most severe pain. In the post-operative setting, the FLACC scale is validated for cognitively intact children up to age 7 years, and was used for all children in the study.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990769


Locations
United States, North Carolina
Duke University Medical Center - Eye Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Heather J Frederick, MD Duke University
More Information
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Responsible Party: Heather Frederick, Dr. Heather Frederick, Duke University
ClinicalTrials.gov Identifier: NCT00990769     History of Changes
Other Study ID Numbers: Pro00015531
First Posted: October 7, 2009    Key Record Dates
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by Heather Frederick, Duke University:
Emergence delirium
Bispectral Index
Depth of anesthesia

Additional relevant MeSH terms:
Psychomotor Agitation
Emergence Delirium
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Delirium
 Confusion
Postoperative Complications
Pathologic Processes
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs