Cardiac Output and Duplex Sonography in Carotid Endarterectomy

Not Applicable

Completed

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

• Registration Number: NCT02230358
• Lead Sponsor: Medical University Innsbruck

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

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regional anesthesia (RA)	invasive arterial blood pressure measurement	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 (RA)	blood gas analysis	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 (RA)	Transcranial Doppler ultrasonography	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 (RA)	Regional anesthesia	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 (RA)	arterial blood gas measurement	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 (RA)	Neurological Control	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 (RA)	NIRS monitoring	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)	General anesthesia	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')
Regional anesthesia (RA)	oxygen supply (not invasive 'Vigileo')	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)	Transcranial Doppler ultrasonography	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 (GA)	invasive arterial blood pressure measurement	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 (GA)	arterial blood gas measurement	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 (GA)	Neurological Control	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 (GA)	blood gas analysis	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 (GA)	oxygen supply (not invasive 'Vigileo')	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 (GA)	NIRS monitoring	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')

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria