Pharmacodynamic interactions between remifentanil and dexmedetomidine (PIRAD)

Completed

• Conditions: gezonde vrijwiligers welk onder anesthesie worden gebracht; Anesthesia administration; Anesthesia monitoring; 10009720

• Registration Number: NL-OMON45644
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- 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

Exclusion Criteria

- Known intolerance to dexmedetomidine or remifentanil;- Volunteer refusal ;- Age < 18 years or >70 years ;- Pregnancy, or currently nursing;- Hairstyle with dreadlocks (EEG-monitoring will not be possible);- Body mass index (BMI) <18 or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary objective is to observe changes in anesthetic depth measured by<br /><br>hypnotic and analgesic endpoints (MOAA/S, response to laryngoscopy and<br /><br>electroencephalogram (EEG) derived indices, during administration of<br /><br>dexmedetomidine or remifentanil and their combination, and to relate these<br /><br>effects to drug concentrations using PKPD modeling (see ch.8 for details). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To improve existing EEG-indices by gaining full EEG-recordings and relate<br /><br>these to the anesthetic effects.<br /><br>- To validate two previously developed TCI models (a dexmedetomidine model and<br /><br>a remifentanil model, see references in our protocol)<br /><br>- To relate ventilatory changes induced by each of the agents and by the<br /><br>combination of both drugs, to the measured drug plasma concentrations.<br /><br>- To relate hemodynamic changes induced by each of the agents and by the<br /><br>combination of both drugs, to the measured drug plasma concentrations. </p><br>