The Neural Mechanisms of Anesthesia and Human Consciousness

• Conditions: o medical condition or disease involved. The study subjects are healthy volunteers.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-001496-21-FI
• Lead Sponsor: Harry Scheinin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 8 February 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Healthy male volunteers will be considered eligible for the study.
The subjects must meet all of the following criteria:
1. Male
2. Age 20–30 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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The subject must be excluded if any of the following criteria are met:
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, 24 hours before sleep studies
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 initial electrophysiological measurements (Parts 2–5)
18. Detected unsuitability based on MRI scanning results (Parts 3–6)
19. Sleep disorder or severe sleep problem

Study & Design

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