Brain Function Monitoring 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.
University of Chicago
100 participants
Aug 6, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria9
- 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
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Interventions
The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06619730