Cardiac Output and Duplex Sonography in Carotid Endarterectomy

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230358
• Other study ID #: CODUCE
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2021
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Procedure:
• Regional anesthesia
Regional anesthesia
• General anesthesia
General anesthesia

Device:
• Transcranial Doppler ultrasonography
6x for 4 hours

Procedure:
• blood gas analysis
6 x 3 ml blood withdrawal (18 ml) within 4 hours
• invasive arterial blood pressure measurement
before operation, 8 hours, as done in clinical routine
• 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
• 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

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Percentage of participants with death.		Up to 6 months
Other	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
Other	Percentage of participants with myocardial infarction.		Up to 6 months
Other	Percentage of participants with stroke.		Up to 6 months
Other	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
Other	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
Primary	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	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