Outcomes of an Intraoperative Bispectral Index Monitor

A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: BIS™ Complete 2--Channel Monitor

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients ages 2-12 scheduled for day surgery at Boston Children's Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BISblind; 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.	Device: BIS™ Complete 2--Channel Monitor; monitor depth of anesthesia
BISvisible; 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.	Device: BIS™ Complete 2--Channel Monitor; monitor depth of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS values	Compare the BIS values in the BISblind and BISvisible groups	intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of intravenous anesthetic medications administered	Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups	intraoperative period
End tidal sevoflurane values	Compare the end tidal sevoflurane values between the BISblind and BISvisible groups	intraoperative period
Agitation/delirium	Determine the incidence of agitation and delirium using the post-anesthesia emergence delirium scale in the post anesthesia care unit	post operative period, until discharge from recovery room, assessed up to 10 hours
Pain scores	Compare the pain scores between the BISblind and BISvisible groups	post operative period, until discharge from recovery room, assessed up to 10 hours
Time to meet discharge criteria	Compare the time needed to meet discharge criteria between the BISblind and BISvisible groups	post operative period, until discharge from recovery room, assessed up to 10 hours

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Keira Mason, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): October 11, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00024412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO