Carotid StenosisNCT02230358
Cardiac Output and Duplex Sonography in Carotid Endarterectomy
A study testing Regional anesthesia, General anesthesia and Transcranial Doppler ultrasonography in people with Carotid Stenosis, run by Medical University Innsbruck at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Regional anesthesia, General anesthesia and Transcranial Doppler ultrasonography
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Elective carotid endarterectomy
- Signed informed consent
Who cannot join
- Age under 18 years
- Missing signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Carotid Stenosis
- Being tested
- Regional anesthesia, General anesthesia, Transcranial Doppler ultrasonography, blood gas analysis, invasive arterial blood pressure measurement
- Keywords
- carotid endarterectomy, cardiac output, trans-cranial Doppler, CEA, regional anesthesia, general anesthesia
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesiaProcedure or surgery
Regional anesthesia
General anesthesiaProcedure or surgery
General anesthesia
Transcranial Doppler ultrasonographyDevice
6x for 4 hours
blood gas analysisProcedure or surgery
6 x 3 ml blood withdrawal (18 ml) within 4 hours
invasive arterial blood pressure measurementProcedure or surgery
before operation, 8 hours, as done in clinical routine
arterial blood gas measurementProcedure or surgery
perioperative, 4-6 times within 8 hours, as done in clinical routine
Neurological ControlBehavioural
perioperative, 2-3 days, as done in clinical routine
NIRS monitoringBehavioural
perioperative, for 5 hours, as done in clinical routine
oxygen supply (not invasive 'Vigileo')Device
perioperative for 5 hours, as done in clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia (RA) | Other | 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') Receives: 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') |
| General anesthesia (GA) | Other | 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') Receives: Procedure: General 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') |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Secondary outcomes (1)
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
Measured: Change of cardiac output from Baseline to induction of anesthesia and up to 1 hour after admission to the intermediate care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priv.Doz. Dr. Corinna Velik-Salchner, Medical University Innsbruck
- Investigators
- Corinna Velik-Salchner, PrivDoz.Dr., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230358
- Sponsor's protocol ID
- CODUCE
- Status last verified
- Sep 2021
- First submitted
- 31 Jul 2014
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output and Cerebral Blood-flow During Carotid Endarterectomy in Regional vs. General Anesthesia. A Prospective Randomized Controlled Single Center Study
- ClinicalTrials.gov ID
- NCT02230358
- Acronym / sponsor ID
- CODUCE
- Conditions
- Carotid Stenosis
- Keywords
- carotid endarterectomy, cardiac output, trans-cranial Doppler, CEA, regional anesthesia, general anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia (RA) | Other | 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')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') |
| General anesthesia (GA) | Other | Procedure: General 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')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') |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years
- Elective carotid endarterectomy
- Signed informed consent
Key exclusion criteria (2 listed)
- Age under 18 years
- Missing signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional anesthesiaRegional anesthesia | Procedure or surgery | Regional anesthesia (RA) |
| General anesthesiaGeneral anesthesia | Procedure or surgery | General anesthesia (GA) |
| Transcranial Doppler ultrasonography6x for 4 hours | Device | General anesthesia (GA), Regional anesthesia (RA) |
| blood gas analysis6 x 3 ml blood withdrawal (18 ml) within 4 hours | Procedure or surgery | General anesthesia (GA), Regional anesthesia (RA) |
| invasive arterial blood pressure measurementbefore operation, 8 hours, as done in clinical routine | Procedure or surgery | General anesthesia (GA), Regional anesthesia (RA) |
| arterial blood gas measurementperioperative, 4-6 times within 8 hours, as done in clinical routine | Procedure or surgery | General anesthesia (GA), Regional anesthesia (RA) |
| Neurological Controlperioperative, 2-3 days, as done in clinical routine | Behavioural | General anesthesia (GA), Regional anesthesia (RA) |
| NIRS monitoringperioperative, for 5 hours, as done in clinical routine | Behavioural | General anesthesia (GA), Regional anesthesia (RA) |
| oxygen supply (not invasive 'Vigileo')perioperative for 5 hours, as done in clinical routine | Device | General anesthesia (GA), Regional anesthesia (RA) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinna Velik-Salchner, PrivDoz.Dr. principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional anesthesia, General anesthesia and Transcranial Doppler ultrasonography in people with Carotid Stenosis, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.