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The aim of this study is to investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.
The investigators will investigate the differences between the cardiac output and the cerebral blood-flow between a regional anesthesia (RA) and a general anesthesia (GA) in a randomized, controlled, single center study at the Medical University Innsbruck, Department of Anesthesia and Intensive Care Medicine.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regional anesthesia (RA) | Other | 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') |
|
| General anesthesia (GA) | Other | 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') |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional anesthesia | Procedure | Regional anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of anesthetic technique on cardiac output during carotid endarterectomy. | Number of participants: 90 patients Unit of measure: Cardiac index (l/m2) Cardiac output will be measured and compared at the following time points:
| Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy. | Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following time points:
|
| Measure | Description | Time Frame |
|---|---|---|
| Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy. | Number of participants: 90 patients Unit of measure: blood flow, volume and absolute tissue saturation Near infrared spectroscopy will be measured and compared at the following time points:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corinna Velik-Salchner, PrivDoz.Dr. | Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
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| General anesthesia |
| Procedure |
General anesthesia |
|
| Transcranial Doppler ultrasonography | Device | 6x for 4 hours |
|
| blood gas analysis | Procedure | 6 x 3 ml blood withdrawal (18 ml) within 4 hours |
|
| invasive arterial blood pressure measurement | Procedure | before operation, 8 hours, as done in clinical routine |
|
| arterial blood gas measurement | Procedure | perioperative, 4-6 times within 8 hours, as done in clinical routine |
|
| Neurological Control | Behavioral | perioperative, 2-3 days, as done in clinical routine |
|
| NIRS monitoring | Behavioral | perioperative, for 5 hours, as done in clinical routine |
|
| oxygen supply (not invasive 'Vigileo') | Device | perioperative for 5 hours, as done in clinical routine |
|
| Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| Influence of anesthetic technique on blood pressure during carotid endarterectomy. | Number of participants: 90 patients Unit of measure: blood pressure in mmHg Blood pressure will be measured and compared at the following time points:
| Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| Percentage of participants with death. | Up to 6 months |
| Number of participants with transient ischemic attack and neck hematoma requiring surgical revision. | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks |
| Percentage of participants with myocardial infarction. | Up to 6 months |
| Percentage of participants with stroke. | Up to 6 months |
| Influence of anesthetic technique on heart rate during carotid endarterectomy | Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit Number of participants: 90 patients Unit of measure: beats per minute (bpm) Heart rate will be measured and compared at the following time points:
| Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| Influence of anesthetic technique on blood gas analysis during carotid endarterectomy | Number of participants: 90 patients Unit of measure: arterial oxygen tension (PaO2) Blood pressure will be measured and compared at the following time points:
| Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000768 | Anesthesia, General |
| D017585 | Ultrasonography, Doppler, Transcranial |
| D001784 | Blood Gas Analysis |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
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