Cardiac Output and Duplex Sonography in Carotid Endarterectomy

Not Applicable

Completed

• Conditions: Carotid Stenosis

• 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

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