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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heather Frederick, Duke University
ClinicalTrials.gov Identifier:
NCT00990769
First received: October 5, 2009
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Emergence Agitation
Other: Depth of anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Time to Emergence From Anesthesia [ Time Frame: After the completion of surgery ] [ Designated as safety issue: No ]
    The time from cessation of anesthesia delivery (Sevoflurane turned off) to extubation.

  • Pain Score: Faces, Legs, Activity, Cry, and Consolability (FLACC) [ Time Frame: Within 30 minutes of arrival in recovery room ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Heather Frederick, Dr. Heather Frederick, Duke University
ClinicalTrials.gov Identifier: NCT00990769     History of Changes
Other Study ID Numbers: Pro00015531
Study First Received: October 5, 2009
Results First Received: April 10, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Psychomotor Disorders
Signs and Symptoms
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014