A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia
- Sponsor
- Boston Children's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- BIS values
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
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.
Investigators
Keira Mason
principal investigator
Boston Children's Hospital
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
Outcomes
Primary Outcomes
BIS values
Time Frame: intraoperative period
Compare the BIS values in the BISblind and BISvisible groups
Secondary Outcomes
- Amount of intravenous anesthetic medications administered(intraoperative period)
- Pain scores(post operative period, until discharge from recovery room, assessed up to 10 hours)
- Time to meet discharge criteria(post operative period, until discharge from recovery room, assessed up to 10 hours)
- End tidal sevoflurane values(intraoperative period)
- Agitation/delirium(post operative period, until discharge from recovery room, assessed up to 10 hours)