Skip to main content
Clinical Trials/EUCTR2013-000119-25-NL
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

masimo0 sites36 target enrollmentFebruary 8, 2013

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.

Registry
who.int
Start Date
February 8, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
masimo

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

Similar Trials