Status:
COMPLETED
Reproducibility of Brain MRI
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Reproducibility of Results
Eligibility:
All Genders
18-35 years
Brief Summary
The aim of this study is to assess the reproducibility over time of functional and structural magnetic resonance imaging, as well as specific biomarkers in plasma in healthy volunteers before and afte...
Detailed Description
In the study 'Neuroplasticity Induced by General Anaesthesia', the investigators intend to explore the effects of general anaesthesia on the brain by state-of-the-art magnetic resonance imaging (MRI)....
Eligibility Criteria
Inclusion
- Age ≥18 ≤35
- Healthy individual
- Normal electrocardiogram (ECG)
- Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
- Speaks and understands Danish
- Provides oral and written informed consent
- Right-handed
- American Society of Anaesthesiologists (ASA) class 1 (2)
- Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation. See Appendix for details)
- BMI ≥18 kg/m2 and ≤30kg/m2
- Female participants must use safe contraceptives.
Exclusion
- Cannot cooperate to tests
- Left-handedness or ambidexterity
- History of cancer, immune disease, autoimmune disease, chronic pain, neurological / psychiatric illness or other serious illness
- Pregnancy
- Weakly intake of \>21 (males) or \>14 (females) units of alcohol
- Substance abuse (assessed by the investigator)
- Daily use of any medication (contraceptives allowed)
- Consumed anti-depressants during the last 30 days before study days
- Heavy intake of caffeine (\> 5 cups/day)
- Smoking during the last 30 days before study days
- Reflux or dyspepsia
- Poor dental status or oral health
- Contraindication to MRI
- Allergy to any kind of medication or material to which the volunteer could be exposed to during this study
- Family history of malignant hyperthermia
- Declines receiving information regarding incidental pathological findings during MRI scans of the brain.
- Otherwise judged unfit for participation by the investigator
- Major trauma or head trauma with any symptoms present at the time of inclusion
- Surgery less than six weeks prior to the study period
- Infection (with fever) less than two weeks prior to the study period
- Expected or suspected difficult airway
- History of complications to general anaesthesia
- Known incident of malignant hyperthermia or unexplained complications to general anaesthesia among close relatives.
- Exclusion criteria during the study (leading to withdrawal):
- Any of the above-mentioned exclusion criteria
- Consumption of more than 3 units of alcohol within 24 hours before each study day (intervention day or MRI scan day)
- Consumed analgesics within 3 days before each study day
- Consumed anti-histamines less than 48 hours before each study day
- Intake of caffeine 12 h prior to each study day
- Smoking
- Major trauma or head trauma during the study period
- Surgery less during the study period
- Fever due to any infection \< 14 days before the study or during the study
Key Trial Info
Start Date :
February 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03876236
Start Date
February 4 2019
End Date
May 4 2019
Last Update
March 10 2021
Active Locations (2)
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1
Department of Neuroanaesthesiology
Glostrup Municipality, Capital Region, Denmark, 2600
2
Functional Imaging Unit, Department for Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup
Glostrup Municipality, Capital Region, Denmark, 2600