Brain Function Monitoring During Surgery (NCT06619730) | Clinical Trial Compass
RecruitingNot Applicable
Brain Function Monitoring During Surgery
United States100 participantsStarted 2024-08-06
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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 p…