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

October 5, 2009
May 30, 2013
September 2009
September 2010   (final data collection date for primary outcome measure)
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.
Pediatric Assessment of Emergence Delirium score [ Time Frame: Within 30 minutes of arrival in recovery room ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00990769 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Emergence Agitation
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: High-normal BIS ("Lighter" anesthesia)
    Depth of anesthesia is titrated to a BIS of 55-60
    Intervention: Other: Depth of anesthesia
  • Experimental: Low-normal BIS ("Deeper" anesthesia)
    Depth of anesthesia is maintained at a BIS level of 40-45
    Intervention: Other: Depth of anesthesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990769
Pro00015531
No
Heather Frederick, Duke University
Duke University
Not Provided
Principal Investigator: Heather J Frederick, MD Duke University
Duke University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP