Changes in the human brain induced by general anaesthesia

Phase 1

• Conditions: 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001252-35-DK
• Lead Sponsor: Kirsten Møller

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-27
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified