The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

• Status: Completed
• Trial end date: 2017-03-13
• Target enrollment: 0
• Participant gender: Male

Summary

Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of the anesthetic (40 dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find chemical fingerprints of acute drug effect.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Turku
• Collaborators: Helsinki University; University of California, Irvine; University of Helsinki; University of Michigan; Yale University
• Treatments: Dexmedetomidine; Esketamine; Ketamine; Propofol; Sevoflurane

Criteria

Inclusion Criteria:

1. Male

2. Age 18-30 years

3. Good general health i.e. American Society of Anesthesiologists (ASA) physical status I

4. Fluent in Finnish language

5. Right handedness

6. Written informed consent

7. Good sleep quality

Exclusion Criteria:

1. Chronic medication

2. History of alcohol and/or drug abuse

3. Strong susceptibility for allergic reactions

4. Serious nausea in connection with previous anesthesia

5. Strong susceptibility for nausea

6. Any use of drugs or alcohol during the 48 hours preceding anesthesia

7. Use of caffeine products 10-12 hours prior the study

8. Smoking

9. Clinically significant previous cardiac arrhythmia / cardiac conduction impairment

10. Clinically significant abnormality in prestudy laboratory tests

11. Positive result in the drug screening test

12. Blood donation within 90 days prior to the study

13. Participation in any medical study with an experimental drug or device during the preceding 60 days

14. The study subject has undergone a prior PET or SPECT study

15. Any contraindication to magnetic resonance imaging (MRI)

16. Hearing impairment

17. Detected unsuitability based on MRI scanning results if available before the PET scanning

18. Sleep disorder or severe sleep problem