We will include 30 healthy volunteers (American Society of Anesthesiologists 1) stratified to age groups to different sequence of anesthesia regimen
Conditions
Sponsors
UMCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A potential subject who meets all of the following criteria can be included in this study: - American Society of Anesthesiologists (ASA) Physical Status 1 - No medical history of significance - No chronic use of medication, drugs, tobacco or more than 20 gr alcohol daily (oral contraceptives excluded). - Concerning the cognitive function: Volunteers are considered to have sufficient cognitive reserve if they are able to read and comprehend the patient information form, if they can adequately answer the anamnestic questions during the screening process and if they are allowed to provide legitimate written informed consent. - No selection will be made regarding ethnic background - No exclusion criterium is present 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Known intolerance to dexmedetomidine or remifentanil - Volunteer refusal - Age 70 years - Pregnancy, or currently nursing - Hairstyle with dreadlocks (EEG-monitoring will not be possible) - Body mass index (BMI) 30 kg/m2. - Neurological disorder (epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, a subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia , schizophrenia, alcohol or drug abuse). - 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) - Recent use of psycho-active medication (benzodiazepines, anti-epileptic drugs, parkinson medication, anti-depressant drugs, opioids) or more than 20 g of alcohol daily. - Bilateral non-patent a. ulnaris - Any other condition relevant to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our objective is to map the pharmacokinetic / pharmacodynamic interaction between dexmedetomidine and remifentanil by observing changes in anesthetic depth, measured by hypnotic and analgesic endpoints such as modified observer’s assessment of alertness and sedation scale (MOAA/S), response to electrical stimuli, response to laryngoscopy and electroencephalogram (EEG) derived indices. These effects will be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling;Secondary Objective: All raw EEG data and recorded vital sign parameters routinely used during anesthesia (cardiac, hemodynamic and respiratory) will be related to both clinical and pharmacological endpoints;Primary end point(s): The relationship between the plasma concentrations of dexmedetomidine and remifentanil and cerebral, hemodynamic and respiratory drug effects as measured by MOAA/S, response to electrical stimuli, response to laryngoscopy, electroencephalogram (EEG) derived indices and routinely used vital signs parameters;Timepoint(s) of evaluation of this end point: 2 years after the last inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All raw EEG data and recorded vital sign parameters routinely used during anesthesia (cardiac, hemodynamic and respiratory) 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 Contactspanjersberg
umcg
Outcome results
None listed