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

Phase 1
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
EUCTR2015-004982-10-FI
Lead Sponsor
Harry Scheinin
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Male
Target Recruitment
Not specified
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

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

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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