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

Phase 4

Completed

• Conditions: Hemodynamic Stability
• Interventions: Drug: xenon; Drug: sévoflurane

• Registration Number: NCT00937807
• Lead Sponsor: Air Liquide Santé International

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-02
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LENOXe™ (xénon 100 % v/v)	xenon	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
sévoflurane	sévoflurane	hypnotic use in standard general anesthesia

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Pitié-Salpêtrière; 🇫🇷 Paris, France