No medical condition or disease involved. The study subjects are healthy volunteers.
Conditions
Interventions
Trade Name: Dexdor
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Dexmedetomidine
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Concentration unit: mg/l millig
Sponsors
Harry Scheinin
Eligibility
Sex/Gender
Male
Inclusion 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 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 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To reveal what happens in the brain when consciousness is impaired by different anesthetic drugs. ;Secondary Objective: To obtain new information about reasons for variability in drug response, new information about differences between anesthetic drugs, and ultimately the mechanisms of action of (general) anesthetics as well as consciousness itself.;Primary end point(s): Due to the exploratory nature of the study no primary variables are defined. This is explained and justified in the study protocol. Analysis of PET and other data is described in detail in section 11 of the protocol. During the study, a series of Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out on 160 healthy male subjects to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine acting through a2-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. The subjects will receive EC50 concentration of dexmedetomidine, propofol, S-ketamine or sevoflurane (40subjects/drug) while being imaged for cerebral metabolic rate of glucose (CMRglu). The intravenous anesthetics will be administered as target-controlled infusions (TCI). EEG will be continuously collected. 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.;Timepoint(s) of evaluation of this end point: Multiple time points. See E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable. See E.5.1.;Timepoint(s) of evaluation of this end point: Not applicable. See E.5.1. | — |
Countries
Finland
Contacts
Public ContactTurku PET Centre
University of Turku
Outcome results
None listed