RECRUITING

Brain Function Monitoring During Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-06

Study Completion:2027-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06619730

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.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Zheng Xie, MD, PhD

CONTACT

773-702-2667

jxie@bsd.uchicago.edu

Al McAuley

CONTACT

773-834-3274

amcauley1@bsd.uchicago.edu

Principal Investigator

Zheng Xie, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06

Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-08-06

Study Completion Date2027-05-01

Terms related to this study

Keywords Provided by Researchers

Brain function Monitoring

Additional Relevant MeSH Terms

Surgery