E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a CT including only healthy volunteers. The aim of the study is to investigate the effect of a commonly used anesthetic drug in clinical concentrations on nociceptive and antinociceptive mechanisms. |
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E.1.1.1 | Medical condition in easily understood language |
This is a CT including only healthy volunteers. The aim of the study is to investigate the effect of a commonly used anesthetic drug in clinical concentrations on pain mechanisms. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
1. To demonstrate a dose-dependency of BOLD-responses in the brain following noxious stimulation for propofol and remifentanil |
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E.2.2 | Secondary objectives of the trial |
2. To demonstrate an influence of propofol and remifentanil on the functional connectivity between brain areas following noxious stimulation 3. To demonstrate an effect of propofol and remifentanil on the diffuse noxious inhibitory controls (DNIC) 4. To investigate and validate surrogate parameters for the noxious perception of an unconscious subject to provide for a monitoring tool for clinical anesthesia and intensive care medicine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent - Age between 18-60 years - No participation in other studies |
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E.4 | Principal exclusion criteria |
- Any light or severe disease - Especially, even in the lightest cases: infection of the respiratory system, muscular diseases, diseases of the CNS, chronic pain diseases, drug or medication abuse - Claustrophobia - Conditions with an increased risk of aspiration, expecially adipositas (BMI>=30kg/m²) - pregnancy or lactation - history or family history of malignant hyperthermia - history or family history of allergic reactions against propofol, remifentanil, soja, latex - Placement in an institution on official authorities order or judicial order - implants, especially pacemakers, cardioverters, cochlea implants, insulin pumps, nerve stimulators, vascular clips, cava filters, metal splints, screws, wires, plates - extensive or looped tattoos, piercings, other ferromagnetic ornaments which cannot be removed - lack of consent to the storage and transmission of data within the scope of the clinical trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
We hypothesize an influence of the anesthetic on the nociceptive structures. Therefore we anticipate under influence of the anesthetic changes in the function of different brain structures visualized using the fMRI, changes in the EEG and changes in responses of nociceptive reflexes. Changes that can be detected at the loss of consciousness can possibly be related to the conscious perception of pain. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During anesthesia, each subject is tested repeatedly for changes in the nociceptive responses. |
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E.5.2 | Secondary end point(s) |
Secondary end points are changes in fMRI-connectivity of pain related signals under anesthesia and changes in clinical surrogates for nociception under anesthesia. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During anesthesia, each subject is tested repeatedly for changes in the nociceptive responses. |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Basic research of pain mechanisms |
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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 | Information not present in EudraCT |
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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Completion of the tests in the designated number of volunteers |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |