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

This study has been completed.
Groupe Hospitalier Pitie-Salpetriere
Information provided by:
Air Liquide Santé International Identifier:
First received: July 9, 2009
Last updated: June 29, 2010
Last verified: June 2010
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 Intervention Phase
Hemodynamic Stability Drug: xenon Drug: sévoflurane Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: July 9, 2009
Last Updated: June 29, 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 processed this record on August 22, 2017