Overview
Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
Status:
Completed
Completed
Trial end date:
2010-04-01
2010-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Air Liquide Santé InternationalCollaborator:
Groupe Hospitalier Pitie-SalpetriereTreatments:
Anesthetics
Sevoflurane
Xenon
Criteria
Inclusion Criteria:- Patients > 55 years, status ASA II
- Carotid endarterectomy elected surgery
- Signed informed consent
Exclusion Criteria:
Related to the patients:
- Histories of hypersensibility in both products used in the study
- uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
- Severe cardiac failure (FEVG < 30 %)
- Major lung or airways disease and\or required per-operating FiO2> 35 %
- Elevated intracranial pressure
- Pregnancy, breast feeding
- Major protected, under supervision, under guardianship
- Every patient entering within the framework of the contraindications indicated to §4.3
of the summary of the characteristics of tested products (LENOXe ™ (xenon 100 % v/v),
sevoflurane)
Related to the surgery:
- Controlateral carotid stenosis superior to 70 % and\or preoperative indication in the
implementation per-operating of a carotid shunt
- Surgery realized within the framework of an emergency
- Combined Surgery