improving Information Extraction from EEG on cerebral anesthetic drug effects
- Conditions
- We will include 36 healthy volunteers (American Society of Anesthesiologists 1) stratified to age groups and randomized to different sequence of anesthesia regimen.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]
- Registration Number
- EUCTR2013-000119-25-NL
- Lead Sponsor
- masimo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 36
- 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
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To observe changes in cerebral activity as measured by EEG and clinical hypnotic and analgesic endpoints (=OAA/S score and response to tetanic stumulus) during administration of propofol or sevoflurane (with or without remifentanil) and to relate these effects to drug concentrations;Secondary Objective: All non-invasive vital sign parameters routinely used during anesthesia (cardiac, hemodynamic, respiratory and photo pleth data, inclusive the Rainbow Acoustic Monitor (Masimo, Irvine, CA, USA) will be related to both clinical and pharmacological endpoint;Primary end point(s): To observe changes in cerebral activity as measured by EEG and clinical hypnotic and analgesic endpoints (=OAA/S score and response to tetanic stumulus) during administration of propofol or sevoflurane (with or without remifentanil) and to relate these effects to drug concentrations;Timepoint(s) of evaluation of this end point: 2 years after the last inclusion
- Secondary Outcome Measures
Name Time Method Secondary end point(s): All non-invasive vital sign parameters routinely used during anesthesia (cardiac, hemodynamic, respiratory and photo pleth data, inclusive the Rainbow Acoustic Monitor (Masimo, Irvine, CA, USA) will be related to both clinical and pharmacological endpoints;Timepoint(s) of evaluation of this end point: 2 years after the last inclusion