Outcomes of an Intraoperative Bispectral Index Monitor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Device: BIS™ Complete 2--Channel Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BISblind<br>The BISblind group will have the BIS monitor and data physically hidden from the anesthesiologist. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. | Device: BIS™ Complete 2--Channel Monitor<br>* monitor depth of anesthesia<br>|
| BISvisible<br>BISvisible group will have the BIS monitor and data available for the anesthesiologist to view. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. | Device: BIS™ Complete 2--Channel Monitor<br>* monitor depth of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BIS values | Compare the BIS values in the BISblind and BISvisible groups | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of intravenous anesthetic medications administered | Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups | intraoperative period | 
| End tidal sevoflurane values | Compare the end tidal sevoflurane values between the BISblind and BISvisible groups | intraoperative period | 
| Agitation/delirium | Determine the incidence of agitation and delirium using the post-anesthesia emergence delirium scale in the post anesthesia care unit | post operative period, until discharge from recovery room, assessed up to 10 hours | 
| Pain scores | Compare the pain scores between the BISblind and BISvisible groups | post operative period, until discharge from recovery room, assessed up to 10 hours | 
| Time to meet discharge criteria | Compare the time needed to meet discharge criteria between the BISblind and BISvisible groups | post operative period, until discharge from recovery room, assessed up to 10 hours |