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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02624401
Other study ID # LOC-2016
Secondary ID
Status Completed
Phase Phase 4
First received November 25, 2015
Last updated March 22, 2017
Start date January 2016
Est. completion date March 13, 2017

Study information

Verified date March 2017
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The explanation of consciousness poses one of the greatest challenges to science and philosophy in the 21st century. It remains unclear what consciousness is and how it emerges from brain activity. 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 acting through α2-agonism, with propofol and sevoflurane both mainly acting through the enhancement of gamma-aminobutyric acid (GABA) system, and with S-ketamine acting through N-methyl-D-aspartate (NMDA) receptor antagonism. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of either dexmedetomidine, propofol, S-ketamine or sevoflurane, or placebo while being imaged for cerebral metabolic rate of glucose (CMRglu). 40 subjects will receive dexmedetomidine, 40 subjects propofol, 20 subjects S-ketamine, 40 subjects sevoflurane and 20 subjects will receive placebo. 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 possible immunological and chemical fingerprints of acute drug effect.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date March 13, 2017
Est. primary completion date March 13, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Intravenous infusion
Propofol
Intravenous infusion
S-ketamine
Intravenous infusion
Sevoflurane
Inhalation
Placebo
Intravenous infusion of saline (Ringer's Acetate)

Locations

Country Name City State
Finland Turku PET Centre Turku

Sponsors (5)

Lead Sponsor Collaborator
University of Turku Helsinki University, University of California, Irvine, University of Michigan, Yale University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Långsjö JW, Alkire MT, Kaskinoro K, Hayama H, Maksimow A, Kaisti KK, Aalto S, Aantaa R, Jääskeläinen SK, Revonsuo A, Scheinin H. Returning from oblivion: imaging the neural core of consciousness. J Neurosci. 2012 Apr 4;32(14):4935-43. doi: 10.1523/JNEUROSCI.4962-11.2012. — View Citation

Långsjo JW, Revonsuo A, Scheinin H. Harnessing anesthesia and brain imaging for the study of human consciousness. Curr Pharm Des. 2014;20(26):4211-24. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Drug concentration in plasma or end-tidal 1 hour
Primary Regional cerebral metabolism of glucose Comparison of responsive and unresponsive subjects 40 min
Secondary EEG 64-channel EEG will be recorded and analyzed using time domain, spectral domain, functional connectivity, directed/effective connectivity and graph theoretical analysis methods. 1 hour
Secondary Immunological effects Blood samples will be draw at baseline (without drug), at the end of study drug administration and after PET scanning for the measurement of approximately 50 cytokines, chemokines and growth factors. 2 hours
Secondary Metabolomic effects Blood samples will be drawn at baseline (without drug), at the end of drug administration and after PET scanning for the measurement of more than 200 serum measures, including lipoprotein subclass distribution and lipoprotein particle concentration, low molecular weight metabolites, such as amino acids, 3-hydroxybutyrate and creatinine, and detailed molecular information on serum lipids, including free and esterified cholesterol, sphingomyelin and fatty acid saturation. 2 hours
Secondary Gene expression Blood samples will be collected at baseline (without drug), at the end of drug administration and after PET scanning for the measurement of RNA expression using whole genome microarray-based, massively parallel sequencing or quantitative reverse-transcription polymerase chain reaction based methods. 2 hours
Secondary Psychological well-being Psychological well-being and ill-being will be measured with a battery of scientifically validated scales just before initiating the study session and at the end of the study session. 2 hours
Secondary Dream report After terminating PET imaging, a structured interview is immediately conducted to verify a recollection or absence of recollection of subjective experiences during possible loss of responsiveness. 1 hour
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