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Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery

2014-08-27 03:13:48 | BioPortfolio

Summary

The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

Description

The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;

Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Conditions

Elevated Cardiac Risk

Intervention

Xenon, Sevoflurane

Location

CHU Nord
Marseille
13
France
13915

Status

Recruiting

Source

Air Liquide Santé International

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:48-0400

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Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a CARDIOVASCULAR DISEASE. It also includes cardiac conditioning and SECONDARY PREVENTION in patients with elevated cardiovascular risk profile.

Stable xenon atoms that have the same atomic number as the element xenon, but differ in atomic weight. Xe-124, 126, 128-131, 134, and 136 are stable xenon isotopes.

Unstable isotopes of xenon that decay or disintegrate emitting radiation. Xe atoms with atomic weights 121-123, 125, 127, 133, 135, 137-145 are radioactive xenon isotopes.

A state of elevated cardiac output due to conditions of either increased hemodynamic demand or reduced cardiac oxygen output. These conditions may include ANEMIA; ARTERIOVENOUS FISTULA; THYROTOXICOSIS; PREGNANCY; EXERCISE; FEVER; and ANOXIA. In time, compensatory changes of the heart can lead to pathological form of high cardiac output and eventual HEART FAILURE.

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