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New treatment option for Surgery
Official title Brain Function Monitoring During Surgery
ClinicalTrials.gov ID: NCT06619730
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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
- people capable of giving informed consent or
- people who have an acceptable surrogate capable of giving consent on behalf of the subject
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- people capable of giving informed consent or
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.