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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Emergence Agitation | Other: Depth of anesthesia | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: High-normal BIS ("Lighter" anesthesia)
Depth of anesthesia is titrated to a BIS of 55-60
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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).
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Experimental: Low-normal BIS ("Deeper" anesthesia)
Depth of anesthesia is maintained at a BIS level of 40-45
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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).
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- 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.
- Time to Emergence From Anesthesia [ Time Frame: After the completion of surgery ]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 ]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.

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Ages Eligible for Study: | 2 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, North Carolina | |
Duke University Medical Center - Eye Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Heather J Frederick, MD | Duke University |
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 |