Understanding brain function during anesthesia with propofol
Investigating Near-Threshold Perception During Anesthetic Sedation
This study is testing how propofol anesthesia affects brain activity and whether ultrasonic brain stimulation can help people wake up faster after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06403852 on ClinicalTrials.gov |
What this trial studies
This study investigates how mental function is affected at different levels of anesthesia using propofol, a commonly used anesthetic. Researchers will utilize functional Magnetic Resonance Imaging (fMRI) to observe brain activity while presenting various visual stimuli, including real and scrambled images, to assess recognition experiences. The study aims to determine if ultrasonic brain stimulation can help accelerate the return to consciousness after anesthesia. Healthy volunteers will be monitored to ensure safety and adherence to strict eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are healthy, right-handed individuals with a BMI under 30 who are English speakers.
Not a fit: Patients with medical contraindications to MRI or those with a history of allergies to propofol or other specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could enhance our understanding of consciousness during anesthesia and improve recovery protocols for patients.
How similar studies have performed: While studies on anesthesia and consciousness exist, this specific approach using fMRI and ultrasonic stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Zirui Huang — University of Michigan
- Study coordinator: Amy McKinney
- Email: adrongo@med.umich.edu
- Phone: 734-647-8129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.