Investigating brain activity during anesthesia induction with propofol
Simultaneous EEG-fMRI Study in Healthy Humans During Induction of Propofol Anesthesia to Investigate the Dynamics of Thalamocortical Functional Connectivity in the Alpha Frequency
This study is trying to see how brain activity changes during anesthesia with propofol and how visual stimulation affects it, especially in older patients, to help improve understanding and treatment of cognitive issues after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Technical University of Munich Academic / other |
| Locations | 2 sites (Munich, Bavaria and 1 other locations) |
| Trial ID | NCT06179719 on ClinicalTrials.gov |
What this trial studies
This observational study explores the neural processes involved in generating intrinsic alpha oscillations during the induction of general anesthesia with propofol. Using simultaneous EEG and fMRI, the study examines how visual stimulation can influence alpha rhythms in the brain during both anesthesia and wakefulness. The primary goal is to understand the mechanisms behind alpha oscillations and their potential impact on conditions like post-operative delirium, particularly in elderly patients. By shedding light on these processes, the study aims to enhance diagnostic and treatment options for related cognitive disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18 to 35 who meet specific health criteria and can provide informed consent.
Not a fit: Patients with a history of neurological or psychiatric disorders, previous brain surgery, or those outside the specified age range will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of post-operative delirium, enhancing patient outcomes after surgery.
How similar studies have performed: While the approach of using EEG-fMRI during anesthesia is innovative, similar studies have shown promise in understanding brain activity, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Munich, Bavaria and 1 other locations
- Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin — Munich, Bavaria, Germany (Recruiting)
- Technische Universität München — München, München (Stadt), Germany (Recruiting)
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.