Clinical trial NCT03052543: Outcomes of an Intraoperative Bispectral Index Monitor
Official title: A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients ages 2-12 scheduled for day surgery at 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.

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

Primary outcomes:
measure: BIS values
timeFrame: intraoperative period
Secondary outcomes:
measure: Amount of intravenous anesthetic medications administered
timeFrame: intraoperative period
measure: End tidal sevoflurane values
timeFrame: intraoperative period
measure: Agitation/delirium
timeFrame: post operative period, until discharge from recovery room, assessed up to 10 hours
measure: Pain scores
timeFrame: post operative period, until discharge from recovery room, assessed up to 10 hours
measure: Time to meet discharge criteria
timeFrame: post operative period, until discharge from recovery room, assessed up to 10 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Keira Mason, MD
role: PRINCIPAL_INVESTIGATOR
References: