Clinical trial NCT02230358: Cardiac Output and Duplex Sonography in Carotid Endarterectomy
Official title: Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Keywords: carotid endarterectomy
cardiac output
trans-cranial Doppler
CEA
regional anesthesia
general anesthesia
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Influence of anesthetic technique on cardiac output during carotid endarterectomy.
timeFrame: Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Secondary outcomes:
measure: Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.
timeFrame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Other outcomes:
measure: Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.
timeFrame: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
measure: Influence of anesthetic technique on blood pressure during carotid endarterectomy.
timeFrame: Change of blood pressure, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
measure: Percentage of participants with death.
timeFrame: Up to 6 months
measure: Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: Percentage of participants with myocardial infarction.
timeFrame: Up to 6 months
measure: Percentage of participants with stroke.
timeFrame: Up to 6 months
measure: Influence of anesthetic technique on heart rate during carotid endarterectomy
timeFrame: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
measure: Influence of anesthetic technique on blood gas analysis during carotid endarterectomy
timeFrame: Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
state: Tirol
Study officials:
affiliation: Medical University Innsbruck
name: Corinna Velik-Salchner, PrivDoz.Dr.
role: PRINCIPAL_INVESTIGATOR
References: