Outcomes of an Intraoperative Bispectral Index Monitor

Sponsor

Boston Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03052543

Collaborator

(none)

Enrollment

Location

19.2

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 7, 2018

Actual Primary Completion Date :

Oct 11, 2019

Actual Study Completion Date :

Oct 11, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

BIS values [intraoperative period]
Compare the BIS values in the BISblind and BISvisible groups

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Boston Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Keira Mason, principal investigator, Boston Children's Hospital

ClinicalTrials.gov Identifier:

NCT03052543

Other Study ID Numbers:

IRB-P00024412

First Posted:

Feb 14, 2017

Last Update Posted:

Oct 14, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Oct 14, 2020