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
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
研究概览
简要总结
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?
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
to determine the changes in cerebral O2 saturation in patient with intraoperative neurological symptoms
时间窗: 15 month
Recording cerebral saturation (INVOS) with each measurement.
to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms
时间窗: 15 month
(aphasia, paresis, loss of consciousness, numbness) occur after clamping the internal carotid artery, and if so, to determine the changes in MCA flow velocity in patient with intraoperative neurological symptoms Recording mean arterial flow velocity with each TCD measurement.
次要结局
- 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?(15 month)
研究者
Tamas Vegh, MD
assistant professor anesthesiologist and intensive care specialist
University of Debrecen