Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
This study has been completed.
Sponsor:
Air Liquide Santé International
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
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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
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 Xenon Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013