Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02665104
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2016-01-13
Brief Title:
Middle Cerebral Artery Velocity and Oxygen Saturation of the Brain During Carotid Endarterectomy
Sponsor:
University of Debrecen
Organization:
University of Debrecen
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 375 ropivacaine 50ml ropivacaine 375 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 375 ropivacaine 50ml ropivacaine 375 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0945792015OTIG | OTHER | Health Registration and Training Center Department of Medical Devices | None |