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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02665104 |
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Date of registration:
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13/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
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Scientific title:
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Investigation of Blood Flow Velocity in the MCA and Oxygen Saturation of the Brain During Carotid Endarterectomy in Local Anesthesia in Patients With and Without Neurological Symptoms Using Transcranial Doppler (TCD) and INVOS Monitor |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02665104 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Hungary
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Contacts
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Name:
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Béla Fülesdi, MD PhD DSci |
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Address:
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Telephone:
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00 36 52 255 347 |
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Email:
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Affiliation:
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Name:
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Béla Fülesdi, MD,PhD,DSci |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hungary University of Debrecen Debrecen, Hungary, 4032 |
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Name:
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Zoltán Mr Gyöngyösi, Md |
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Address:
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Telephone:
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+3630/2883970 |
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Email:
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zozman77@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 100 patients awaiting carotid artery endarterectomy carried out in regional
anesthesia.
- Age: patients over 18 years.
- Gender: both female and male patients are included in the study.
- Medical equipment: venous catheter, arterial catheter for invasive blood pressure
monitoring.
- Bilateral continuous measurement of the middle cerebral arteries with Transcranial
Doppler.
- Bilateral continuous measurement of the cerebral saturation with INVOS monitor.
Exclusion Criteria:
- Allergy to ropivacaine, bupivacaine.
- Patients who does not consent to the awake surgery or does not sign the informed
consent of the study.
- If the patient is either psychologically or neurologically unsuitable for the awake
surgery.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cerebral Oxygen Saturation,MCA Velocity,Intraoperative Neurological Symptoms During Carotid Endarterectomy
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Intervention(s)
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Device: transcranial Doppler (TCD) and INVOS monitor
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Primary Outcome(s)
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to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
[Time Frame: 15 month]
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to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
[Time Frame: 15 month]
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Secondary Outcome(s)
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the degree of change in the measured parameters during clamp and declamp after the internal carotid artery is clamped, if there is any difference between the operated and non-operated sides?
[Time Frame: 15 month]
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Secondary ID(s)
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094579/2015/OTIG
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DE RKEB/IKEB:4364/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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