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Outcomes of an Intraoperative Bispectral Index Monitor

NCT03052543 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2020-10-14

No results posted yet for this study

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.

Conditions

  • Anesthesia

Interventions

DEVICE

BIS™ Complete 2--Channel Monitor

monitor depth of anesthesia

Sponsors & Collaborators

Principal Investigators

  • Keira Mason, MD · Boston Children's Hospital

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2019-10-11
Completion
2019-10-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03052543 on ClinicalTrials.gov