Cardiac Output and Duplex Sonography in Carotid Endarterectomy

Medical University Innsbruck

Status: Completed

Conditions: Carotid Stenosis

Treatments: Procedure: Regional anesthesia; Behavioral: Neurological Control; Behavioral: NIRS monitoring; Device: Transcranial Doppler ultrasonography; Device: oxygen supply (not invasive 'Vigileo'); Procedure: General anesthesia; Procedure: arterial blood gas measurement; Procedure: invasive arterial blood pressure measurement; Procedure: blood gas analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02230358

CODUCE

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Regional anesthesia (RA)

Other group

Description:

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')

Treatment:

Device: oxygen supply (not invasive 'Vigileo')

Behavioral: Neurological Control

Procedure: invasive arterial blood pressure measurement

Procedure: Regional anesthesia

Procedure: arterial blood gas measurement

Device: Transcranial Doppler ultrasonography

Behavioral: NIRS monitoring

Procedure: blood gas analysis

General anesthesia (GA)

Other group

Description:

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')

Treatment:

Device: oxygen supply (not invasive 'Vigileo')

Behavioral: Neurological Control

Procedure: invasive arterial blood pressure measurement

Procedure: General anesthesia

Procedure: arterial blood gas measurement

Device: Transcranial Doppler ultrasonography

Behavioral: NIRS monitoring

Procedure: blood gas analysis