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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 years study duration

Study Start

First participant enrolled

July 1, 2014

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed

1 month until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed

Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

July 31, 2014

Last Update Submit

September 6, 2021

Conditions

Carotid Stenosis

Keywords

carotid endarterectomycardiac outputtrans-cranial DopplerCEAregional anesthesiageneral anesthesia

Outcome Measures

Primary Outcomes (1)

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: * 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
Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Secondary Outcomes (1)

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

Other Outcomes (8)

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
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
Percentage of participants with death.
Up to 6 months
+5 more other outcomes

Study Arms (2)

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')

Procedure: Regional anesthesiaDevice: Transcranial Doppler ultrasonographyProcedure: blood gas analysisProcedure: invasive arterial blood pressure measurementProcedure: arterial blood gas measurementBehavioral: Neurological ControlBehavioral: NIRS monitoringDevice: 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')

Procedure: General anesthesiaDevice: Transcranial Doppler ultrasonographyProcedure: blood gas analysisProcedure: invasive arterial blood pressure measurementProcedure: arterial blood gas measurementBehavioral: Neurological ControlBehavioral: NIRS monitoringDevice: oxygen supply (not invasive 'Vigileo')

Interventions

Regional anesthesiaPROCEDURE

Regional anesthesia

Regional anesthesia (RA)

General anesthesiaPROCEDURE

General anesthesia

General anesthesia (GA)

Transcranial Doppler ultrasonographyDEVICE

6x for 4 hours