E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We will include 30 healthy volunteers (American Society of
Anesthesiologists 1) stratified to age groups to different
sequence of anesthesia regimen |
|
E.1.1.1 | Medical condition in easily understood language |
We will include 30 healthy volunteers (American Society of
Anesthesiologists 1) stratified to age groups to different
sequence of anesthesia regimen. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 years after the last inclusion |
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E.5.2 | 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 years after the last inclusion |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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2 years after the last patient visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |