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Completed

NCT Number: NCT03052543

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.

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Key information

Conditions

Anesthesia

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS™ Complete 2--Channel Monitor

Device

monitor depth of anesthesia

Primary outcomes

  1. BIS values

    Time frame: intraoperative period

    Compare the BIS values in the BISblind and BISvisible groups

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 14, 2017
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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