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 | 10007687 |
E.1.2 | Term | Carotid artery stenosis |
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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 |
Compare the hemodynamic stability in ASA class 2-3 patients scheduled for an carotid endarterectomy surgery during general anesthesia maintained by Xenon or Desflurane.
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E.2.2 | Secondary objectives of the trial |
- Compare the recovery characteristics in patients scheduled for an carotid endarterectomy surgery after general anesthesia maintained by Xenon or Desflurane. - Compare the quality of clinical recovery in patients scheduled for an carotid endarterectomy surgery after general anesthesia maintained by Xenon or Desflurane. - Compare the incidence of postoperative myocardial ischemia after carotid endarterectomy surgery under general anesthesia maintained by Xenon or Desflurane.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients of more than 18 years old. - ASA 2 -3 patients scheduled for carotid endarterectomy under general anesthesia. - Have given his/her writing informed consent to participate in the study. - Patients able to understand the protocol of the study. - Patients having a national health insurance .
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E.4 | Principal exclusion criteria |
- Patients having contraindication general anesthesia under Xenon a. The patient requiring a high FiO2 b. Respiratory insufficient chronic patient c. History of asthma d. History of chronic obstructive pulmonary disease e. History of pneumothorax or intraocular bubbles f. History of known hypersensitivity in the active substance g. History of malignant hyperthermia h. Elevated intra-cranial pressure i. Patients suffering from lung diseases and\or from air traffics j. Patients requiring a concentration brought up in oxygen k. Coronary artery Diseases and\or severe cardiac insufficency
- Patients having contraindication general anesthesia under Desflurane a. History of known hypersensitivity to halogenated agents b. Personal or family history of malignant hyperthermia c. Patients having hepatic failure, a cholestasis, an unexplained fever, or a previous rise of eosinophilia after administration of a halogenated agent.
- Patients deprived of freedom by a court or administrative order, adults under guardianship or guardianship, persons staying in a sanitary or social establishment.
- Pregnant or breast-feeding women, women in age to procreate not having an effective contraception (hormonal / mechanical: per os, injectable, transcutaneous, implantable, intra-uterine device, either surgical: ligature of trunks, hysterectomy, total ovariectomy )
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E.5 End points |
E.5.1 | Primary end point(s) |
The number of hypotensive events, defined as a mean arterial pressure less than 70 mmHg, observed in the two groups.
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | Yes |
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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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 | 8 |
E.8.9.1 | In the Member State concerned days | 5 |