Outcomes of an Intraoperative Bispectral Index Monitor

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052543
• Other study ID #: IRB-P00024412
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: October 11, 2019

Study information

• Verified date: October 2020
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• BIS™ Complete 2--Channel Monitor
monitor depth of anesthesia

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS values	Compare the BIS values in the BISblind and BISvisible groups	intraoperative period
Secondary	Amount of intravenous anesthetic medications administered	Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups	intraoperative period
Secondary	End tidal sevoflurane values	Compare the end tidal sevoflurane values between the BISblind and BISvisible groups	intraoperative period
Secondary	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
Secondary	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
Secondary	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