E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054799 |
E.1.2 | Term | Perioperative analgesia |
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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 |
Investigate the relationship between the calculated Cet of remifentanil and the parameters from HRV et APV before a standard noxious stimulation during general anesthesia at calibrated hypnosis level |
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E.2.2 | Secondary objectives of the trial |
1. To investigate the relationship between calculated Cet of remifentanil and parameters from HRV and APV after a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
2. To investigate the relationship between parameters from HRV and APV and pupil size or dilatation before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
3. To investigate the relationship between parameters from HRV and APV and pupil size or dilatation after a standard noxious stimulation during general anesthesia at calibrated hypnosis level.
4. The changes in BIS and haemodynamic measurements will also be recorded and compared with parameters from HRV and APV and pupil size or dilatation to determine the probability of these parameters to predict a haemodynamic response or a movement during calibrated noxious stimulation.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 to 55 years old ASA status 1 or 2 Patients scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medular surgery, ear, nose or throat surgery or orthopedic surgery) Gived informed consent before the study |
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E.4 | Principal exclusion criteria |
patient admit to emergency surgery or to eye surgery patient with propofol allergy or remifentanil allergy Patient who has had a anesthesia between the 7 days before the study Patient with a pacemaker Patient with a transplant heart Patient with previous history of parkinson disease, of diabetes, of chonic ethylism, Patient with cardiac or autonomic disease Patient with alpha or beta bloquant treatment Patient with anti arythmic treatment Patient allergic to soy or to peanut Hypersensitivity to fentanyl derivatives or to one or mors Ultiva and Propofol excipient |
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E.5 End points |
E.5.1 | Primary end point(s) |
Relationship between LFVFC (a low frequency region = sympathetic activity), HFVPA higt frequency region = parasympathetic activity), LFVPA (sympathetic activity), HFVPA (parasympathetic activity) and opioid cerebral concentrations before and after nociceptive stimulation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
other concentration of remifentanil |
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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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5 minutes before nociceptive stimulation |
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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 | 1 |
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 | 1 |
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 |