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

Study Overview
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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.

Official Title
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Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE

Conditions
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Hemodynamic Stability

Intervention / Treatment
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* Drug: xenon
* Drug: sévoflurane


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sévoflurane<br>hypnotic use in standard general anesthesia | Drug: sévoflurane<br>* Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery<br>|
| Experimental: LENOXe™ (xénon 100 % v/v)<br>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 | Drug: xenon<br>* Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used |  | Pre-op, every min from 1-90 min during maintenance phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient |  | During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodynamic stability, xenon, carotid surgery, general anesthesia