Status:
COMPLETED
Neuroplasticity Induced by General Anaesthesia
Lead Sponsor:
Signe Sloth Madsen
Conditions:
Healthy Volunteers
General Anaesthesia
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
The aim of this study is to use magnetic resonance imaging to explore and compare possible de novo neuroplastic changes induced by the isolated effects of the hypnotic agents sevoflurane and propofol,...
Detailed Description
Background In the perioperative period, severe changes can be observed in the endocrine, immune, and nervous system. These changes are called the surgical stress response. Clinically, this can be obs...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤35.
- Healthy individual.
- BMI ≥18 kg/m2 and ≤30kg/m2.
- Normal electrocardiogram (ECG).
- Normal physical examination, including neurological examination, auscultation of the heart and lungs, and measurement of blood pressure and pulse.
- American Society of Anaesthesiologists (ASA) class 1.
- Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details.
- Right-handed.
- Female participants must use safe contraceptives (hormonal or mechanical, including intrauterine devices).
- Speaks and understand Danish.
- Provides oral and written informed consent.
Exclusion
- Contraindications to MRI.
- Left-handedness or ambidexterity.
- History of complications to general anaesthesia, including malignant hyperthermia.
- Family history of malignant hyperthermia.
- Known incident of malignant hyperthermia or any unexplained complication to general anaesthesia among close relatives.
- Allergy to any kind of medication or material to which the volunteer could be exposed during this study.
- History of serious illness.
- History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness.
- 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 or during the study sessions.
- Daily use of any medication (not counting contraceptives).
- Consumed anti-depressants during the last 30 days before study days.
- Weakly intake of \>21 (for females \>14) units of alcohol.
- Heavy intake of caffeine (\> 5 cups/day).
- Smoking during the last 30 days before study days.
- Substance abuse (assessed by the investigator).
- Pregnancy
- Reflux or dyspepsia.
- Poor dental status or oral health.
- Expected or suspected difficult airway.
- Declines receiving information regarding accidental pathological findings during MRI scans of the brain.
- Cannot cooperate to tests.
- Otherwise judged unfit for participation by the investigator.
- Exclusion Criteria during the study:
- Any of the above-mentioned exclusion criteria.
- Major trauma or head trauma during the study period.
- Surgery during the study period.
- Infection (with fever) during the study period.
- 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
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04125121
Start Date
September 26 2019
End Date
August 13 2021
Last Update
August 20 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