EUCTR2013-000119-25-NL
Active, not recruiting
Not Applicable
Study of the cerebral effects of sevoflurane, propofol and remifentanil as measured by the spontaneous electro-encephalogram
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- We will include 36 healthy volunteers (American Society of Anesthesiologists 1) stratified to age groups and randomized to different sequence of anesthesia regimen.
- Sponsor
- masimo
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Healthy volunteers aged 18 to 70 years.
- •\- No selection will be made regarding ethnic background.
- •\- For this study no control group has been selected as EEG is compared between episodes rather than between individuals (each volunteer is his/her own control)
- •\- We will select volunteers in order to obtain sufficient spread in the data concerning age and gender and location of the electrodes used
- •18\-35 y 6 men / 6 women
- •35\-50 y 6 men / 6 women
- •50\-70 y 6 men / 6 women
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •\- Volunteer refusal
- •\- Volunteer \< 18 years and \>70 years
- •\- Exclusion criteria are weight less than 70% or more than 130% of ideal body weight
- •\- Neurological disorder
- •\- Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator
- •\- Pulmonary diseases
- •\- Gastric diseases
- •\- Endocrinologic diseases
- •\- Recent use of psycho\-active medication or more than 20 g of alcohol daily.
Outcomes
Primary Outcomes
Not specified
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