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Haemodynamic effects of xenon or sevoflurane anesthesia on microcirculatio

Phase 1
Conditions
Patients with ASA III classification (left ventricular failure) undergoing implantation of a defibrillator.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2013-004582-14-BE
Lead Sponsor
Department of Anesthesiology and Perioperative Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

patients with Left ventricular ejection fraction <30% undergoing the insertion of a defibrillator >18y-75y
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

patients with ASA I and ASA II.
<18y
Normal LV function

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: The aim of the study is the assessment of microcirculatory alterations induced by xenon or sevoflurane anesthesia in patients with compromised left ventricular systolic function.;Secondary Objective: Hemodynamic effects of xenon or sevoflurane anesthesia in patients with compromised left ventricular systolic function.;Primary end point(s): Microcirculatory changes induced by xenon or sevoflurane anesthesia.;Timepoint(s) of evaluation of this end point: Once the adequate anesthetic level (i.e. .6 of xenon or sevoflurane concentration measured by the anesthetic machine) is obtained with xenon or sevoflurane, microcirculation is assessed.<br>
Secondary Outcome Measures
NameTimeMethod
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A
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