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Behavioural Intervention

Brain Monitoring for Surgery

N/A
Recruiting
Led By Zheng Xie, MD, PhD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned surgery duration between 60-240 minutes under specific types of anesthesia
American Society of Anesthesiology Physical Status Classification Grade of 1 to Grade 3
Must not have
American Society of Anesthesiology Physical Status Classification Grade of 4,5,6
History of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the Sedline Brain Function Monitor to see if it can help improve recovery after anesthesia. Researchers want to find out if monitoring brain activity during anesthesia can lead to earlier discharge and fewer

Who is the study for?
This trial is for healthy adults aged 18-45 undergoing planned surgeries lasting 1-4 hours under specific anesthesia, who can consent to participate. It's open to all genders and contraception users but excludes those with allergies to anesthetic agents, seizure history, emergency surgery patients, or those unable to use the Sedline monitor.
What is being tested?
The study tests if monitoring brain activity with the Sedline Brain Function Monitor during anesthesia improves recovery outcomes like earlier discharge and fewer side effects. It also examines gender differences in response to anesthetics with this monitoring.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from wearing the monitor leads or possible inaccuracies in monitoring that could affect anesthesia management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My surgery is expected to last 1 to 4 hours under certain anesthesia.
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My health is good to moderately impaired according to anesthesia standards.
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health is severely impaired, making me a high-risk patient for surgery.
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I have a history of seizures.
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I am having emergency surgery.
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I do not want to participate in the study.
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I am not having surgery that would interfere with Sedline monitor leads placement.
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I received spinal or nerve block anesthesia for my surgery.
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I am on gender-affirming hormone therapy.
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My scheduled surgery is expected to last less than 60 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Speed of recovery time
Secondary study objectives
Difference in recovery times between males and females
To assess patient satisfaction with their anesthetic experience and side effects.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Control ArmActive Control1 Intervention
Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.
Group II: Sedline Monitor ArmActive Control1 Intervention
Anesthesia care guided by Sedline brain function monitor during the procedure.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,048 Previous Clinical Trials
758,549 Total Patients Enrolled
5 Trials studying Surgery
2,264 Patients Enrolled for Surgery
Zheng Xie, MD, PhDPrincipal InvestigatorUniversity of Chicago
~67 spots leftby May 2026
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