Clinical trial NCT00937807: Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
Official title: Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Stability
Keywords: hemodynamic stability
xenon
carotid surgery
general anesthesia
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Groupe Hospitalier Pitie-Salpetriere
First posted: 2009-07-13
Enrollment: 84
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Pre-op, every min from 1-90 min during maintenance phase
Secondary outcomes:
measure: 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
timeFrame: 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
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Pitié-Salpêtrière
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Pierre CORIAT, Pr
role: PRINCIPAL_INVESTIGATOR
References: