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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemodynamic Stability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sévoflurane

hypnotic use in standard general anesthesia

Group Type ACTIVE_COMPARATOR

sévoflurane

Intervention Type DRUG

Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

LENOXe™ (xénon 100 % v/v)

Safety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person

Group Type EXPERIMENTAL

xenon

Intervention Type DRUG

Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Interventions

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xenon

Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Intervention Type DRUG

sévoflurane

Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No