PD interaction of DMED and REMI

Phase 1

• Conditions: We will include 30 healthy volunteers (American Society ofAnesthesiologists 1) stratified to age groups to differentsequence of anesthesia regimen; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]

• Registration Number: EUCTR2017-000945-37-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-04
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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 < 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 clinical trial of medicinal product
• Study Design: Not specified