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

Hemodynamic Stability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937807
• Other study ID #: ALS-8-09-A-401
• Secondary ID: EUDRACT 2009-012
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2009
• Last updated: June 29, 2010
• Start date: July 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamic Stability

Intervention

Drug:
• xenon
Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
• sévoflurane
Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery

Locations

Country	Name	City	State
France	Hospital Pitié-Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Pre-op, every min from 1-90 min during maintenance phase	Yes
Secondary	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		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	Yes