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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00937807
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : June 30, 2010
Groupe Hospitalier Pitie-Salpetriere
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hemodynamic Stability Drug: xenon Drug: sévoflurane Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: sévoflurane
hypnotic use in standard general anesthesia
Drug: sévoflurane
Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
Experimental: 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
Drug: xenon
Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Primary Outcome Measures :
  1. 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 [ Time Frame: Pre-op, every min from 1-90 min during maintenance phase ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 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 ]

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00937807

Hospital Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Air Liquide Santé International
Groupe Hospitalier Pitie-Salpetriere
Principal Investigator: Pierre CORIAT, Pr groupe hospitalier Pitié-Salpêtrière

Responsible Party: Catherine Billoët, MD, Air Liquide Santé International Identifier: NCT00937807     History of Changes
Other Study ID Numbers: ALS-8-09-A-401
EUDRACT 2009-012810-29
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: June 2010

Keywords provided by Air Liquide Santé International:
hemodynamic stability
carotid surgery
general anesthesia

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General