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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Duke University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00990769
First received: October 5, 2009
Last updated: May 25, 2010
Last verified: May 2010
History of Changes
  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:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pediatric Assessment of Emergence Delirium score [ Time Frame: Within 30 minutes of arrival in recovery room ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to emergence from anesthesia [ Time Frame: After the completion of surgery ] [ Designated as safety issue: No ]
  • RASS sedation score [ Time Frame: Within 30 minutes of arrival in recovery room ] [ Designated as safety issue: No ]
  • Pain score (age appropriate - FLACC or FACES) [ Time Frame: Within 30 minutes of arrival in recovery room ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2009
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-normal BIS
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
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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990769

Contacts
Contact: Heather J Frederick, MD 919-812-6204 heather.frederick@duke.edu

Locations
United States, North Carolina
Duke University Medical Center - Eye Center Recruiting
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, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00990769     History of Changes
Other Study ID Numbers: Pro00015531
Study First Received: October 5, 2009
Last Updated: May 25, 2010
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
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013