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Completed

NCT Number: NCT02230358

Cardiac Output and Duplex Sonography in Carotid Endarterectomy

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 18 years
  • Elective carotid endarterectomy
  • Signed informed consent

Exclusion criteria

  • Age under 18 years
  • Missing signed informed consent

Treatment and study plan

Regional Anesthesia

Procedure

Regional anesthesia

General Anesthesia

Procedure

General anesthesia

Transcranial Doppler ultrasonography

Device

6x for 4 hours

blood gas analysis

Procedure

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

invasive arterial blood pressure measurement

Procedure

before operation, 8 hours, as done in clinical routine

arterial blood gas measurement

Procedure

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

Neurological Control

Behavioral

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

NIRS monitoring

Behavioral

perioperative, for 5 hours, as done in clinical routine

oxygen supply (not invasive 'Vigileo')

Device

perioperative for 5 hours, as done in clinical routine

Primary outcomes

  1. Influence of anesthetic technique on cardiac output during carotid endarterectomy.

    Time frame: 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 outcomes

  1. Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.

    Time frame: 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

Other outcomes

  1. Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.

    Time frame: Change of cardiac output from 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: blood flow, volume and absolute tissue saturation

    Near infrared spectroscopy 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

  2. Influence of anesthetic technique on blood pressure during carotid endarterectomy.

    Time frame: Change of blood pressure, from 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: blood pressure in mmHg

    Blood pressure 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

  3. Percentage of participants with death.

    Time frame: Up to 6 months

  4. Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

  5. Percentage of participants with myocardial infarction.

    Time frame: Up to 6 months

  6. Percentage of participants with stroke.

    Time frame: Up to 6 months

  7. Influence of anesthetic technique on heart rate during carotid endarterectomy

    Time frame: Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

    Change of heart rate, from 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: beats per minute (bpm)

    Heart rate 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

  8. Influence of anesthetic technique on blood gas analysis during carotid endarterectomy

    Time frame: Change of oxygen saturation in blood, from 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: arterial oxygen tension (PaO2)

    Blood pressure 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

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 3, 2014
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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