Status:
COMPLETED
Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
Lead Sponsor:
Air Liquide Santé International
Collaborating Sponsors:
Groupe Hospitalier Pitie-Salpetriere
Conditions:
Hemodynamic Stability
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 eld...
Eligibility Criteria
Inclusion
- Patients \> 55 years, status ASA II
- Carotid endarterectomy elected surgery
- Signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00937807
Start Date
July 1 2009
End Date
April 1 2010
Last Update
September 11 2025
Active Locations (1)
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1
Hospital Pitié-Salpêtrière
Paris, France, 75013