Outcomes of an Intraoperative Bispectral Index Monitor

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Boston Children's Hospital

Status

Completed

Conditions

Anesthesia

Treatments

Device: BIS™ Complete 2--Channel Monitor

Study type

Observational

Funder types

Other

Identifiers

NCT03052543
IRB-P00024412

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

BISblind
Description:
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.
Treatment:
Device: BIS™ Complete 2--Channel Monitor
BISvisible
Description:
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.
Treatment:
Device: BIS™ Complete 2--Channel Monitor

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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