Monitoring brain function during surgery
Using Brain Function Monitors to Guide Anesthetic Management in Improving Anesthesia Recovery: a Randomized Pilot Study to Compare Outcomes in Young Adult Patients.
This study tests if using a special brain monitor during surgery can help people recover faster and feel better afterwards, while also looking at how men and women react differently to anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06619730 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of the Sedline Brain Function Monitor in monitoring brain activity during anesthesia. The study will assess whether this monitoring can lead to improved recovery outcomes, such as earlier discharge and reduced side effects. Participants will be randomly assigned to a monitoring group where their brain function will be closely observed, and adjustments to anesthesia will be made based on specific brain activity readings. The study also seeks to understand if there are differences in how males and females respond to anesthetics with and without brain monitoring.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-45 scheduled for surgeries lasting between 60-240 minutes.
Not a fit: Patients with severe life-threatening conditions or those with allergies to anesthetic agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery times and minimize side effects for patients undergoing surgery.
How similar studies have performed: Other studies have shown promise in using brain function monitoring during anesthesia, suggesting potential benefits in patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Pregnant women will not be strictly excluded from this study if they meet all other criteria. Exclusion Criteria: * 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
Where this trial is running
Chicago, Illinois
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Zheng Xie, MD, PhD — University of Chicago
- Study coordinator: Zheng Xie, MD, PhD
- Email: jxie@bsd.uchicago.edu
- Phone: 773-702-2667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.