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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00937807

Enrollment

Registered

2009-07-13

Start date

2009-07-31

Completion date

2010-04-30

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Stability

Keywords

hemodynamic stability, xenon, carotid surgery, general anesthesia

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.

Interventions

DRUGxenon

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

DRUGsévoflurane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026