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

This study has been completed.
Sponsor:
Collaborator:
Groupe Hospitalier Pitie-Salpetriere
Information provided by:
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT00937807
First received: July 9, 2009
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937807

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

No publications provided

Responsible Party: Catherine Billoët, MD, Air Liquide Santé International
ClinicalTrials.gov 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
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on October 01, 2014