Overview

Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Air Liquide Santé International
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Treatments:
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