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临床试验/EUCTR2013-001496-21-FI
EUCTR2013-001496-21-FI进行中(未招募)不适用

The Neural Mechanisms of Anesthesia and Human Consciousness - The Neural Mechanisms of Anesthesia and Human Consciousness

Harry Scheinin0 个研究点开始时间: 2013年6月10日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • Healthy male volunteers will be considered eligible for the study.
  • The subjects must meet all of the following criteria:
  • 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

排除标准

  • 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
  • 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

研究者

发起方
Harry Scheinin

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