Outcomes of an Intraoperative Bispectral Index Monitor
- Conditions
- Anesthesia
- Interventions
- Device: BIS™ Complete 2--Channel Monitor
- Registration Number
- NCT03052543
- Lead Sponsor
- Boston Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- orthopedic or urologic day surgery
- 2 to 12 years old
- anesthesiologist refusal
- patient/parent refusal
- allergy to the BIS adhesive
- history of seizures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BISvisible BIS™ Complete 2--Channel Monitor 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. BISblind BIS™ Complete 2--Channel Monitor 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.
- Primary Outcome Measures
Name Time Method BIS values intraoperative period Compare the BIS values in the BISblind and BISvisible groups
- Secondary Outcome Measures
Name Time Method Amount of intravenous anesthetic medications administered intraoperative period Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups
Pain scores post operative period, until discharge from recovery room, assessed up to 10 hours Compare the pain scores between the BISblind and BISvisible groups
Time to meet discharge criteria post operative period, until discharge from recovery room, assessed up to 10 hours Compare the time needed to meet discharge criteria between the BISblind and BISvisible groups
End tidal sevoflurane values intraoperative period Compare the end tidal sevoflurane values between the BISblind and BISvisible groups
Agitation/delirium post operative period, until discharge from recovery room, assessed up to 10 hours Determine the incidence of agitation and delirium using the post-anesthesia emergence delirium scale in the post anesthesia care unit
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States