Anesthesia Clinical Trial
Official title:
Investigating Near-Threshold Perception During Anesthetic Sedation
The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia, and to evaluate if the use of ultrasonic brain stimulation accelerates return to consciousness. Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Healthy study subjects with American Society of Anesthesiologists (ASA)-1 status. - Right-handed - Body mass index (BMI) less than 30. - All subjects will be English speakers. Exclusion Criteria: - Medical contraindication to magnetic resonance imaging (MRI) scanning; are unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding, BMI>30, metallic substances in the body, claustrophobia, anxiety, or cardiopulmonary disease; or have an intracranial structural abnormality on T1-weighted MRI scans. - History of allergy to propofol, eggs or egg products, soybean or soybean products, neurological, cardiovascular, or pulmonary illness; significant head injury with loss of consciousness; learning disability or other developmental disorder; sleep apnea or any severe snoring history; gastroesophageal reflux disease (GERD) or heartburn; pancreatitis or a history of pancreatitis, or sensory/motor loss sufficient to interfere with performance of the study. - Tattoos in the head or neck region will be excluded from study; other tattoos are subject to determination by investigators based on their assessment regarding participant safety. To eliminate aspiration risk subjects will also be excluded if they have had recent food or liquid intake (within 8 hours). - History of drug use, have a positive drug screen, are unwilling to abstain from alcohol for 24 hours prior to dosing, or have a current history of nicotine use. - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of General Medical Sciences (NIGMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Oxygen Level Dependent (BOLD) response to visual stimuli | Visual stimuli evoked activity was quantified by measurements of the fMRI BOLD signal. Neural response to a natural visual stimulus will be assessed during both conscious and anesthetized states. | Up to 90 minutes | |
Secondary | Perceptual criterion (c) derived from the Signal Detection Theory (SDT) | Up to 90 minutes | ||
Secondary | Sensitivity (d') criterion derived from the Signal Detection Theory (SDT) | Up to 90 minutes |
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