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Completed

NCT Number: NCT00937807

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

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.

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Key information

Conditions

Hemodynamic Stability

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

sévoflurane

Drug

Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • Groupe Hospitalier Pitie-Salpetriere

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 13, 2009
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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