Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06619730

Brain Function Monitoring During Surgery

Led by University of Chicago · Updated on 2024-10-03

100

Participants Needed

1

Research Sites

142 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Brain Function Monitoring During Surgery

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • American Society of Anesthesiology Physical Status Classification Grade of 1 (normal, healthy patient) to Grade 3 (patient with severe disease)
  • Age between 18 and 45 years old
  • Planned surgery duration between 60 and 240 minutes under general anesthesia with endotracheal tube or laryngeal mask airway
  • Able to give informed consent or have an acceptable surrogate to provide consent
  • All contraception methods allowed; participants may opt-out of pregnancy testing if they prefer
  • Pregnant women may participate if they meet other criteria
Not Eligible

You will not qualify if you...

  • American Society of Anesthesiology Physical Status Classification Grade 4, 5, or 6 (life-threatening disease or no survival possibility)
  • Allergies to commonly used anesthetic agents
  • History of seizures
  • Undergoing emergency surgery
  • Refusal to participate in the study
  • Surgery preventing placement of Sedline monitor leads (e.g., forehead/scalp surgery)
  • Receiving neuraxial anesthesia or peripheral nerve block as part of anesthetic
  • Taking gender-affirming hormonal medications
  • Scheduled surgery duration less than 60 minutes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

Z

Zheng Xie, MD, PhD

CONTACT

A

Al McAuley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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