Cardiac Output and Duplex Sonography in Carotid Endarterectomy
NCT ID: NCT02230358
Last Updated: 2021-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-07-31
2017-07-31
Brief Summary
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Detailed Description
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For this purpose patients with the need of a carotid endarterectomy (CEA) will be included and randomized either to the regional anesthesia (RA) or the general anesthesia (GA) group until a patient number of 45 in each group is achieved.
The cardiac output and cerebral blood-flow via trans-cranial Doppler (TCD) will be measured at 6 time points:
* T0 Baseline (after insertion of an arterial line)
* T1 After induction of anesthesia, but before surgical start
* T2 Two minutes after clamping the carotid artery
* T3 Two minutes after shunt insertation of the carotid artery
* T4 After reperfusion
* T5 After completion of the skin suture
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Regional anesthesia (RA)
Regional anesthesia (RA) for a carotid endarterectomy Interventions: Regional anesthesia (RA), blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, Near-infrared spectroscopy (NIRS) monitoring, oxygen supply (not invasive 'Vigileo')
Regional anesthesia
Regional anesthesia
Transcranial Doppler ultrasonography
6x for 4 hours
blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
Neurological Control
perioperative, 2-3 days, as done in clinical routine
NIRS monitoring
perioperative, for 5 hours, as done in clinical routine
oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
General anesthesia (GA)
General anesthesia (GA) for a carotid endarterectomy Interventions: General anesthesia, blood gas analysis, 'Transcranieller Doppler' (Transcranial Doppler ultrasonography), invasive arterial blood pressure measurement, arterial blood gas measurement, neurological control, NIRS monitoring, oxygen supply (not invasive 'Vigileo')
General anesthesia
General anesthesia
Transcranial Doppler ultrasonography
6x for 4 hours
blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
Neurological Control
perioperative, 2-3 days, as done in clinical routine
NIRS monitoring
perioperative, for 5 hours, as done in clinical routine
oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
Interventions
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Regional anesthesia
Regional anesthesia
General anesthesia
General anesthesia
Transcranial Doppler ultrasonography
6x for 4 hours
blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
arterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
Neurological Control
perioperative, 2-3 days, as done in clinical routine
NIRS monitoring
perioperative, for 5 hours, as done in clinical routine
oxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
Eligibility Criteria
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Inclusion Criteria
2. Elective carotid endarterectomy
3. Signed informed consent
Exclusion Criteria
2. Missing signed informed consent
18 Years
ALL
No
Sponsors
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Medical University Innsbruck
OTHER
Responsible Party
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Priv.Doz. Dr. Corinna Velik-Salchner
Priv.-Doz. Dr.
Principal Investigators
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Corinna Velik-Salchner, PrivDoz.Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University Innsbruck
Locations
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Medical University Innsbruck
Innsbruck, Tyrol, Austria
Countries
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Other Identifiers
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CODUCE
Identifier Type: -
Identifier Source: org_study_id
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