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Clinical Trials/EUCTR2015-004982-10-FI
EUCTR2015-004982-10-FI
Active, not recruiting
Phase 1

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

Harry Scheinin0 sitesNovember 27, 2015
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Conditionso 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]
DrugsDexdorPropofol-Lipuro 10 mg/mlKetanest_a 25 mg/mlSevorane 100%

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
o medical condition or disease involved. The study subjects are healthy volunteers.
Sponsor
Harry Scheinin
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 27, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Harry Scheinin

Eligibility Criteria

Inclusion Criteria

  • •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

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
  • •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

Outcomes

Primary Outcomes

Not specified

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