CompletedPhase 4ketamine

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

Sponsored by University of Turku

NCT ID
NCT02624401
Target Enrollment
160 participants
Start Date
2016-01
Est. Completion
2017-03-13

About This Study

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.

Conditions Studied

AnesthesiaUnconsciousness

Interventions

  • Dexmedetomidine
  • Propofol
  • S-ketamine
  • Sevoflurane
  • Placebo

Eligibility

Sex:MALE
Age:18 Years - 30 Years
Healthy Volunteers:Yes
View full eligibility 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

Study Locations (1)

Turku PET Centre
Turku, Finland

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source