Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
All Genders
Healthy Volunteers
NCT06179719

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

Age: 18Years - 35Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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