Outcomes of an Intraoperative Bispectral Index Monitor

NCT ID: NCT03052543

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2019-10-11

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.

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.

Conditions

Anesthesia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BIS™ Complete 2--Channel Monitor

Intervention Type: DEVICE

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.

BIS™ Complete 2--Channel Monitor

Intervention Type: DEVICE

monitor depth of anesthesia

Interventions

BIS™ Complete 2--Channel Monitor

monitor depth of anesthesia

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Keira Mason

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keira Mason, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IRB-P00024412

Identifier Type: -

Identifier Source: org_study_id