Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outcomes of an Intraoperative Bispectral Index Monitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052543
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Keira Mason, 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.

Condition or disease Intervention/treatment
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.

Layout table for study information
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 : March 7, 2018
Actual Primary Completion Date : October 11, 2019
Actual Study Completion Date : October 11, 2019

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




Primary Outcome Measures :
  1. BIS values [ Time Frame: intraoperative period ]
    Compare the BIS values in the BISblind and BISvisible groups


Secondary Outcome Measures :
  1. Amount of intravenous anesthetic medications administered [ Time Frame: intraoperative period ]
    Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups

  2. End tidal sevoflurane values [ Time Frame: intraoperative period ]
    Compare the end tidal sevoflurane values between the BISblind and BISvisible groups

  3. Agitation/delirium [ Time Frame: 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

  4. Pain scores [ Time Frame: post operative period, until discharge from recovery room, assessed up to 10 hours ]
    Compare the pain scores between the BISblind and BISvisible groups

  5. Time to meet discharge criteria [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
60 patients ages 2-12 scheduled for day surgery at Boston Children's Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052543


Locations
Layout table for location information
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Keira Mason, MD Boston Children's Hospital
Layout table for additonal information
Responsible Party: Keira Mason, principal investigator, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03052543    
Other Study ID Numbers: IRB-P00024412
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No