Brain Function Monitoring During Surgery

Description

The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor, and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery, including earlier discharge and less side effects. Furthermore, the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring.

Conditions

Surgery

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Study Overview

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Study Details

Study overview

The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor, and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery, including earlier discharge and less side effects. Furthermore, the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring.

Using Brain Function Monitors to Guide Anesthetic Management in Improving Anesthesia Recovery: a Randomized Pilot Study to Compare Outcomes in Young Adult Patients.

Brain Function Monitoring During Surgery

Condition
Surgery
Intervention / Treatment

-

Contacts and Locations

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * American Society of Anesthesiology Physical Status Classification Grade of 1(normal, healthy patient) to Grade 3 (patient with severe disease)
  • * Between ages 18-45 years old
  • * Planned surgery duration between 60-240 minutes General-endotracheal-tube-anesthesia or general anesthesia with laryngeal mask airway
  • * Subjects capable of giving informed consent or
  • * Subjects who have an acceptable surrogate capable of giving consent on behalf of the subject
  • * All contraception methods will be allowable for any subject in this study. Participants may opt-out of a pregnancy test if they would prefer to proceed with surgery without one.
  • * American Society of Anesthesiology Physical Status Classification Grade of 4,5,6 (diseases that are life threatening or no possibility of survival)
  • * Listed allergies to any commonly used anesthetic agents
  • * History of seizures, as a seizure while using brain monitoring may influence the anesthesia provider in a way that is not aligned with the purpose of this study
  • * Any patient undergoing emergency surgery, as can not be ensured that consent will be able to be properly obtained
  • * Patient refusal to participate in study
  • * Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp)
  • * Patients who receive neuraxial anesthesia or a peripheral nerve block as part of their anesthetic
  • * Patients who are taking gender-affirming hormonal medications, as this can affect the response to anesthetics
  • * The duration of surgery scheduled \<60 minutes

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Chicago,

Zheng Xie, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2027-05-01