Carotid artery stenosis MedDRA version: 12.1 Level: LLT Classification code 10007687 Term: Carotid artery stenosis
Conditions
Interventions
Trade Name: LENOXE 100%
Pharmaceutical Form: Inhalation vapour*
Trade Name: SUPRANE
Pharmaceutical Form: Inhalation vapour*
Sponsors
CHU de Poitiers
Eligibility
Sex/Gender
All
Inclusion criteria
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 . 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 )
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the hemodynamic stability in ASA class 2-3 patients scheduled for an carotid endarterectomy surgery during general anesthesia maintained by Xenon or Desflurane. ;Secondary Objective: - 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. ;Primary end point(s): The number of hypotensive events, defined as a mean arterial pressure less than 70 mmHg, observed in the two groups. | — |
Countries
France
Outcome results
None listed