NCT06179719 EEG-fMRI Experiments During Anesthesia Induction With Propofol
| NCT ID | NCT06179719 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technical University of Munich |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-09-10 |
| Primary Completion | 2024-09-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2023-09-10 with a primary completion date of 2024-09-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06179719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06179719 currently recruiting?
Yes, NCT06179719 is actively recruiting participants. Visit ClinicalTrials.gov or contact Technical University of Munich to inquire about joining.
Where is the NCT06179719 trial being conducted?
This trial is being conducted at Munich, Germany, München, Germany.
Who is sponsoring the NCT06179719 clinical trial?
NCT06179719 is sponsored by Technical University of Munich. The trial plans to enroll 35 participants.