Cardiac Output and Duplex Sonography in Carotid Endarterectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Carotid Stenosis
• Intervention / Treatment: Procedure: Regional 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'); Procedure: General anesthesia

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medical University Innsbruck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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')	Procedure: Regional anesthesia; Regional anesthesia; Device: Transcranial Doppler ultrasonography; 6x for 4 hours; Procedure: blood gas analysis; 6 x 3 ml blood withdrawal (18 ml) within 4 hours; Procedure: invasive arterial blood pressure measurement; before operation, 8 hours, as done in clinical routine; Procedure: arterial blood gas measurement; perioperative, 4-6 times within 8 hours, as done in clinical routine; Behavioral: Neurological Control; perioperative, 2-3 days, as done in clinical routine; Behavioral: NIRS monitoring; perioperative, for 5 hours, as done in clinical routine; Device: oxygen supply (not invasive 'Vigileo'); perioperative for 5 hours, as done in clinical routine
Other: 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')	Device: Transcranial Doppler ultrasonography; 6x for 4 hours; Procedure: blood gas analysis; 6 x 3 ml blood withdrawal (18 ml) within 4 hours; Procedure: invasive arterial blood pressure measurement; before operation, 8 hours, as done in clinical routine; Procedure: arterial blood gas measurement; perioperative, 4-6 times within 8 hours, as done in clinical routine; Behavioral: Neurological Control; perioperative, 2-3 days, as done in clinical routine; Behavioral: NIRS monitoring; perioperative, for 5 hours, as done in clinical routine; Device: oxygen supply (not invasive 'Vigileo'); perioperative for 5 hours, as done in clinical routine; Procedure: General anesthesia; General anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of anesthetic technique on trans-cranial doppler flow during carotid endarterectomy.	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	Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of anesthetic technique on near infrared spectroscopy during carotid endarterectomy.	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	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.	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	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
Number of participants with transient ischemic attack and neck hematoma requiring surgical revision.		Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Percentage of participants with myocardial infarction.		Up to 6 months
Percentage of participants with stroke.		Up to 6 months
Influence of anesthetic technique on heart rate during carotid endarterectomy	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	Change of heart rate, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Influence of anesthetic technique on blood gas analysis during carotid endarterectomy	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	Change of oxygen saturation in blood, from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Principal Investigator: Corinna Velik-Salchner, PrivDoz.Dr., Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: general anesthesia; carotid endarterectomy; regional anesthesia; cardiac output; CEA; trans-cranial Doppler
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CODUCE