Actively Recruiting
EEG-fMRI Experiments During Anesthesia Induction With Propofol
Led by Technical University of Munich · Updated on 2023-12-22
35
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study aims to investigate healthy cortical and subcortical neural processes involved in generating intrinsic alpha oscillations during induction of general anesthesia with propofol. To do this, the investigators have designed a simultaneous electroencephalogram (EEG)- MRI (functional MRI and Spectroscopy) experiment with a visual stimulation paradigm that addresses the subject's specific intrinsic alpha rhythm during anesthesia and wakefulness. The main question it aims to answer is: could the investigators address the alpha oscillation system of the healthy brain with external stimulation during anesthesia? This experiment could lead to a better understanding of the mechanisms underlying the generation of alpha oscillations. It could open new doors to diagnostic and treatment options for diseases where alpha oscillations, such as post-operative delirium, seem to be affected.
CONDITIONS
Official Title
EEG-fMRI Experiments During Anesthesia Induction With Propofol
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria:
- Female and male healthy individuals (ASA I: assessed according to the American Society of Anesthesiologists Physical Status Classification System a non-acute or chronic disease), non-pregnant, non-smokers, non-drug-users, and presenting no or minimal alcohol use.
- Age: 18 to 35 years
- Capacity to give consent
- Written consent after detailed information.
Exclusion criteria:
- Individuals who do not meet all inclusion criteria
- Previous brain surgery
- History of epileptic seizures
- History of psychiatric or neurological disease
- Physical status other than American Society of Anesthesiologists physical status I, e.g., presence of severe internal or systemic disease
- Chronic intake of medication or drugs (Alcohol, Marihuana, Cocaine, Opioids, Benzodiazepine, etc.)
- Impaired hearing or presence of deafness
- Absence of fluency in the German language
- Known disposition to malignant hyperthermia
- Previous diagnosis of hepatic porphyria
- Body mass index greater than 30 kg/m2
- Gastrointestinal disorders with a disposition for gastroesophageal regurgitation
- Known or suspected difficult airway
- Known hypersensitivity to propofol or any propofol injectable emulsion components (i.e., eggs, eggs products, soybeans, or soy products)
- Atopy/severe allergies/asthma
- Cardiological abnormalities: torsades de pointes, prolonged QT interval, QT changes present since birth.
- Contraindications to MRI (e.g., pacemakers, artificial heart valves, cardioseal, aneurysm clips, implanted magnetic metal parts (screws, plates from surgery), cochlear implants, metal splitters/grenade splinters, acupuncture needle, insulin pump, piercings that cannot be removed, etc)
- Pregnancy
- Subjects with claustrophobia
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin
Munich, Bavaria, Germany, 81675
Actively Recruiting
2
Technische Universität München
München, München (Stadt), Germany, 80686
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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