Current Environment:

Summary

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.

Conditions

Anesthesia

Recruitment Status

Completed

Detailed Description

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Device

BIS™ Complete 2--Channel Monitor

Gender

All

Minimum Age

2 Years

Maximum Age

12 Years

Download Date

October 14, 2020

Principal Investigator

Keira Mason

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: