Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-02-01 @ 1:01 PM
Study NCT ID:
NCT02665104
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2016-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
Sponsor:
University of Debrecen
Organization:
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2017-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Detailed Description:
Investigation of blood flow velocity in the middle cerebral artery and oxygen saturation of the brain bilaterally during carotid endarterectomy carried out in local anesthesia in patients with and without neurological symptoms using transcranial Doppler (TCD) and INVOS monitor.
Zoltán Gyöngyösi Study protocol
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Patients and Methods
Outpatient examination, preparation and anesthesia of the patients:
* ECG test
* Echocardiography, if it is necessary due to the cardial status of the patient.
* Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.
Surgical anesthesia:
* Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)
* Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.
* In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.
Intraoperative measurements:
* Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
* Recording mean arterial pressure with each TCD measurement.
* Recording cerebral saturation (INVOS) with each TCD measurement.
* Recording any anti-hypertensive therapy in the postoperative phase.
* Recording heart rate.
* Recording arterial oxygen saturation.
* Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped.
Zoltán Gyöngyösi Study protocol
The primary endpoint of our study is to determine whether neurological symptoms (aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, changes showed by transcranial Doppler or INVOS monitor is more sensitive regarding the symptoms? Secondary endpoint: the degree of change in the measured parameters after the internal carotid artery is clamped, and if there is any difference between the operated and non-operated sides?
Patients and Methods
Outpatient examination, preparation and anesthesia of the patients:
* ECG test
* Echocardiography, if it is necessary due to the cardial status of the patient.
* Indication of surgical intervention provided by the cerebrovascular outpatient clinic, with attached carotid ultrasound and angiography results.
Surgical anesthesia:
* Superficial and deep cervical block with 3.75% ropivacaine (50ml ropivacaine 3.75%) (incase of allergy bupivacaine should be used)
* Securing venous catheter, infusion of Lactated-Ringer or Voluven solution.
* In case of pain topical administration of Lidocaine by the surgeon, intravenous administration of 25-50ug Fentanyl or 1 vial of Algopyrin.
Intraoperative measurements:
* Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
* Recording mean arterial pressure with each TCD measurement.
* Recording cerebral saturation (INVOS) with each TCD measurement.
* Recording any anti-hypertensive therapy in the postoperative phase.
* Recording heart rate.
* Recording arterial oxygen saturation.
* Recording the patients' neurological status with each TCD measurement and continuous neurological monitoring while the internal carotid artery is clamped.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 094579/2015/OTIG | OTHER | Health Registration and Training Center Department of Medical Devices | View |