Cardiac Output and Duplex Sonography in Carotid Endarterectomy

NCT ID: NCT02230358

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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

Conditions

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Carotid Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Regional anesthesia (RA)

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')

Group Type OTHER

Regional anesthesia

Intervention Type PROCEDURE

Regional anesthesia

Transcranial Doppler ultrasonography

Intervention Type DEVICE

6x for 4 hours

blood gas analysis

Intervention Type PROCEDURE

6 x 3 ml blood withdrawal (18 ml) within 4 hours

invasive arterial blood pressure measurement

Intervention Type PROCEDURE

before operation, 8 hours, as done in clinical routine

arterial blood gas measurement

Intervention Type PROCEDURE

perioperative, 4-6 times within 8 hours, as done in clinical routine

Neurological Control

Intervention Type BEHAVIORAL

perioperative, 2-3 days, as done in clinical routine

NIRS monitoring

Intervention Type BEHAVIORAL

perioperative, for 5 hours, as done in clinical routine

oxygen supply (not invasive 'Vigileo')

Intervention Type DEVICE

perioperative for 5 hours, as done in clinical routine

General anesthesia (GA)

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')

Group Type OTHER

General anesthesia

Intervention Type PROCEDURE

General anesthesia

Transcranial Doppler ultrasonography

Intervention Type DEVICE

6x for 4 hours

blood gas analysis

Intervention Type PROCEDURE

6 x 3 ml blood withdrawal (18 ml) within 4 hours

invasive arterial blood pressure measurement

Intervention Type PROCEDURE

before operation, 8 hours, as done in clinical routine

arterial blood gas measurement

Intervention Type PROCEDURE

perioperative, 4-6 times within 8 hours, as done in clinical routine

Neurological Control

Intervention Type BEHAVIORAL

perioperative, 2-3 days, as done in clinical routine

NIRS monitoring

Intervention Type BEHAVIORAL

perioperative, for 5 hours, as done in clinical routine

oxygen supply (not invasive 'Vigileo')

Intervention Type DEVICE

perioperative for 5 hours, as done in clinical routine

Interventions

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Regional anesthesia

Regional anesthesia

Intervention Type PROCEDURE

General anesthesia

General anesthesia

Intervention Type PROCEDURE

Transcranial Doppler ultrasonography

6x for 4 hours

Intervention Type DEVICE

blood gas analysis

6 x 3 ml blood withdrawal (18 ml) within 4 hours

Intervention Type PROCEDURE

invasive arterial blood pressure measurement

before operation, 8 hours, as done in clinical routine

Intervention Type PROCEDURE

arterial blood gas measurement

perioperative, 4-6 times within 8 hours, as done in clinical routine

Intervention Type PROCEDURE

Neurological Control

perioperative, 2-3 days, as done in clinical routine

Intervention Type BEHAVIORAL

NIRS monitoring

perioperative, for 5 hours, as done in clinical routine

Intervention Type BEHAVIORAL

oxygen supply (not invasive 'Vigileo')

perioperative for 5 hours, as done in clinical routine

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Priv.Doz. Dr. Corinna Velik-Salchner

Priv.-Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Corinna Velik-Salchner, PrivDoz.Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Innsbruck

Locations

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Medical University Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Countries

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Austria

Other Identifiers

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CODUCE

Identifier Type: -

Identifier Source: org_study_id

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