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

Air Liquide

Status and phase

Completed

Phase 4

Conditions

Hemodynamic Stability

Treatments

Drug: xenon

Drug: sévoflurane

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00937807

ALS-8-09-A-401

EUDRACT 2009-012810-29

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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