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Table 1 Inclusion and exclusion criteria

From: Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers

Inclusion criteria Exclusion criteria
• Age ≥ 18 and ≤ 35 years
• Healthy individual
• BMI ≥ 18 kg/m2 and ≤ 30 kg/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 [44]
• Mallampati I-II and simplified airway risk index (SARI) 0–2 (i.e. no indication of difficult intubation). See Tables 2 and 3 for details
• Right-handed
• Female participants must use safe contraceptives (hormonal or mechanical, including IUDs)
• Speaks and understands Danish
• Provides oral and written informed consent
• Contraindications to MRI (as described below)
• 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 psychiatric illness
• History of neurological disease with permanent neurological deficits or ongoing neurodegeneration
• Major trauma or head trauma with any symptoms present at the time of inclusion
• Surgery less than 6 weeks prior to the study period
• Infection (with fever) less than 2 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
• Weekly intake of > 21 (for women > 14) units of alcohol
• Heavy intake of caffeine (>  5 cups/day)
• Smoking during the last 30 days before study days
• Substance misuse (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 (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 h 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 h before each study day
• Intake of caffeine 12 h prior to each study day
• Smoking
  1. BMI body mass index, IUD intrauterine contraceptive device, MRI magnetic resonance imaging
  2. Contraindications to MRI Contraindications to MRI include the following: severe claustrophobia rendering the subject unable to undergo MRI without administration of one or more sedatives or anaesthetics, pacemaker implant, artificial heart valve, cochlear/stapes prosthetics, irremovable insulin pump, neurostimulator, metal clips from previous surgical procedures, other metallic foreign objects, shrapnel or shell splinter, the presence of intravascular catheters other than a peripheral intravenous catheter, shunts and drainage tubes