This trial investigates the effects of general anaesthesia on the helathy human brain. Thus, only healthy, young adults with no medical conditions will participate as volunteers in this study.
Conditions
Interventions
Trade Name: Sevorane, sevoflurane
Pharmaceutical Form: Inhalation vapour, liquid
Trade Name: Propofol
Product Name: Propofol
Pharmaceutical Form: Emulsion for injection/infusion
Sponsors
Kirsten Møller
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age =18 and =35 • Healthy individual • BMI =18 kg/m2 and =30kg/m2 • American Society of Anaesthesiologists (ASA) class 1 (61) • Mallampati I-II and simplified airway risk index (SARI) 0-2 (i.e. no indication of difficult intubation). See appendix for details. • Female participants must use safe contraceptives (hormonal or mechanical, including IUDs). • Speaks and understand Danish • Provides oral and written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Reflux or dyspepsia • Poor dental status or oral health • Expected or suspected difficult airway • Allergy to any kind of medication or material to which the volunteer could be exposed during this study • Contraindication to MRI • 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 period • History of complications to general anaesthesia • Family history of malignant hyperthermia • Known incident of malignant hyperthermia or unexplained complication to general anaesthesia among close relatives. • History of cancer, immune disease, autoimmune disease, chronic pain or neurological / psychiatric illness • 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 • Substance abuse (assessed by the investigator) • Heavy intake of caffeine (> 5 cups/day) • Smoking during the last 30 days before study days • 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 (leading to withdrawal): • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore and compare possible the de novo neuroplastic changes (visualised by magnetic resonnance imaging (MRI)) induced by anaesthesia with a volatile agent (sevoflurane) and total intravenous anaesthesia (propofol) respectively. ;Secondary Objective: To elucidate possible associations between MRI findings and clinical as well as biochemical outcomes. ;Primary end point(s): Volume and morphology of selected brain regions and anatomical structures as recorded by T1w3D anatomy MRI, and white matter microstructure as measured using Diffusion Tensor Imaging (DTI). ;Timepoint(s) of evaluation of this end point: Before general anaesthesia (baseline), after general anaesthesia (on the same day), one day after general anaesthesia, and one week (7-10 days) after general anaesthesia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Identical with primary end points. ;Secondary end point(s): 1. Differences in resting state functional MRI (rsfMRI) induced by GA. 2. Severity and characteristics of of fatigue, as measured by Multidimensional Fatigue Inventory (MFI-20). 3. Cognitive function including attention, speed and executive function as measured by computer-based neuropsychological tests (Paced Auditory Serial Addition Test(PASAT), Test of Attentional Performance (TAP), and Conners Continuous Performance Test 3rd edition (CPT3)). 4. Quality of Recovery – 15-item questionnaire. 5. Immune function and biochemical markers analysed by the following methods: Whole blood gene expression profiling, flow cytometry, in vitro stimulation of peripheral blood mononuclear cells, cytokine immune assays, and organ-specific biochemical markers as described below. 6. Autonomic nervous system activity as measured using Heart Rate Variability (HRV). 7. Correlations between MRI findings as well as clinical and biochemical outcomes as described above. | — |
Countries
Denmark
Contacts
Public ContactGlostrup
Rigshospitalet
Outcome results
None listed