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Completed
NCT06403852
Investigating Near-Threshold Perception During Anesthetic Sedation
Conditions: Propofol, Anesthesia, fMRI
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 40
Sponsor: University of Michigan
Location: University of Michigan Ann Arbor Michigan
Summary
The researchers expect to gain a deeper understanding of mental function during different levels of anesthesia.
Propofol is FDA approved for use in patients undergoing an anesthetic for medical treatment but is not approved for use in healthy volunteers.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06403852). StuddyBuddy aggregates publicly available trial information.