Status:
RECRUITING
EEG-fMRI Experiments During Anesthesia Induction With Propofol
Lead Sponsor:
Technical University of Munich
Conditions:
Anesthesia
Eligibility:
All Genders
18-35 years
Phase:
NA
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....
Detailed Description
This study aims to investigate healthy cortical and subcortical neural processes during induction of general anesthesia with propofol, which is clinically relevant for postoperative delirium, a common...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06179719
Start Date
September 10 2023
End Date
September 10 2026
Last Update
December 22 2023
Active Locations (2)
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1
Klinikum rechts der Isar - Klinik für Anästhesiologie und Intensivmedizin
Munich, Bavaria, Germany, 81675
2
Technische Universität München
München, München (Stadt), Germany, 80686