Anesthesia
Conditions
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.
Interventions
DEVICEBIS™ Complete 2--Channel Monitor
monitor depth of anesthesia
Sponsors
Boston Children's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS values | intraoperative period | Compare the BIS values in the BISblind and BISvisible groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of intravenous anesthetic medications administered | intraoperative period | Compare the amount of intravenous anesthetic medications administered 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 |
| 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 |
Countries
United States
Outcome results
None listed