Outcomes of an Intraoperative Bispectral Index Monitor



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:2 - 12
Updated:4/17/2018
Start Date:March 7, 2018
End Date:December 2019
Contact:Erin Halpin, MSN
Email:erin.halpin@childrens.harvard.edu
Phone:857-218-4585

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A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor

This pilot study is being conducted to determine whether the intraoperative presence of a
Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and
postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to
the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in
adult and pediatric studies it has been shown to decrease time to emergence, decrease
volatile anesthesia requirement, decrease recovery time and in some cases, decrease
post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,
when BIS is present but not specifically designated to be used as a monitor to guide
anesthesia delivery, has not been specifically examined. This will be the first pediatric
study which applies BIS on all patients and randomizes the anesthesiologists to either be or
not be privy to seeing the BIS values during intra-operative period.

The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves.
In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence,
decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease
post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters,
when BIS is present but not specifically designated to be used as a monitor to guide
anesthesia delivery, has not been specifically examined. This will be the first pediatric
study which applies BIS on all patients and randomizes the anesthesiologists to either be or
not be privy to seeing the BIS values during intra-operative period.

Inclusion Criteria:

- orthopedic or urologic day surgery

- 2 to 12 years old

Exclusion Criteria:

- anesthesiologist refusal

- patient/parent refusal

- allergy to the BIS adhesive

- history of seizures
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 857-218-4585
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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mi
from
Boston, MA
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