Carotid Stenosis
Conditions
Keywords
carotid endarterectomy, cardiac output, trans-cranial Doppler, CEA, regional anesthesia, general anesthesia
Brief summary
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.
Detailed description
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: * 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
Interventions
PROCEDURERegional anesthesia
Regional anesthesia
PROCEDUREGeneral anesthesia
General anesthesia
6x for 4 hours
PROCEDUREblood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
PROCEDUREinvasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
PROCEDUREarterial blood gas measurement
perioperative, 4-6 times within 8 hours, as done in clinical routine
BEHAVIORALNeurological Control
perioperative, 2-3 days, as done in clinical routine
BEHAVIORALNIRS monitoring
perioperative, for 5 hours, as done in clinical routine
DEVICEoxygen supply (not invasive 'Vigileo')
perioperative for 5 hours, as done in clinical routine
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>= 18 years 2. Elective carotid endarterectomy 3. Signed informed consent
Exclusion criteria
1. Age under 18 years 2. Missing signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Influence of anesthetic technique on cardiac output during carotid endarterectomy. | 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: Cardiac index (l/m2) Cardiac output will be measured and compared at the following 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy. | Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit | Cerebral blood flow will be measured via trans-cranial Doppler (TCD) and compared at the following 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Influence of anesthetic technique on blood pressure during carotid endarterectomy. | Change of blood pressure, 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: blood pressure in mmHg Blood pressure will be measured and compared at the following 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 |
| 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 | 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: * 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 |
| Influence of anesthetic technique on blood gas analysis during carotid endarterectomy | Change of oxygen saturation in blood, 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: arterial oxygen tension (PaO2) Blood pressure will be measured and compared at the following 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 |
| Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy. | Change of cardiac output 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: blood flow, volume and absolute tissue saturation Near infrared spectroscopy will be measured and compared at the following 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 |
Countries
Austria
Outcome results
None listed