We will include 36 healthy volunteers (American Society of Anesthesiologists 1) stratified to age groups and randomized to different sequence of anesthesia regimen.
Conditions
Interventions
Trade Name: remifentanil
Product Name: ultiva
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Remifentanil
CAS Number: 132875-61-7
Other descriptive name: REMIFENTANIL HYDROC
Sponsors
masimo
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
Exclusion criteria: - Volunteer refusal - Volunteer 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactEVP Clinical Developmenl and Market
masimo
Outcome results
None listed