Evaluation of the Effect of Interscalene Block on Intracranial Pressure by Sonographic Measurements of Optic Nerve Sheath Diameter and Internal Jugular Vein Collapsibility Index
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Optic nerve sheath diameter change
研究概览
简要总结
The study aims to show the effects of interscalene brachial plexus (ISBP) block on intracranial pressure by measuring optic nerve sheath diameter (ONSD) and internal vein collapsibility index (IJV-CI).
详细描述
40 is the targeted number of patients who are going to have humerus fracture or opened rotator-cuff surgery. Single shot-ISBP block with 25 ml local anesthetic will be performed as anesthetic approach for surgery to all participants. Intraoperative ONSD and IJV-CI measurements will be performed before the ISBP block, 20 minutes and 60 minutes after the block. Hypothesis; external drug-volume effect on internal jugular vein causes decreasing maximum diameter of internal jugular vein (Dmax), venous return from cranium to heart decreases, intracranial pressure can increase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had elective humeral fracture and open rotator-cuff surgery,
- •Patients aged 18-85 years,
- •Patients have ASA I-II anesthesia risk according to the American Society of Anesthesiologists (ASA) risk classification,
- •Patients that gave consent for participation in the study will be included.
排除标准
- •Patients who do not give consent to the study,
- •Patients with infection and open wounds in the area of skin puncture and eyelids,
- •Patients have any history of intracranial pathology,
- •Patients have nerve blockade contraindications such as coagulation disorder and antithrombotic-anticoagulant use,
- •Patients have a history of allergy to one of the study drugs,
- •Patients have a body mass index over 35 kg/m2,
- •Patients with contralateral pneumothorax,
- •Patients with severe respiratory distress,
- •Patients with uncontrolled hypertension,
- •Patients with acute or chronic eye disease,
- •Patients with previous eye surgery,
- •Patients using a beta-blocker known to increase intraocular pressure,
- •Patients using calcium channel blockers, statins and nitrates,
- •Patients in need of intraoperative sedation,
- •Patients who develope any complications (hoarseness, horner's syndrome, respiratory distress, local anesthetic toxicity) due to ISBP block will be excluded from the study.
结局指标
主要结局
Optic nerve sheath diameter change
时间窗: Optic nerve sheath diameter will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute and change between basal and 20th minute will be assessed
Optic nerve sheath diameter will be measured as a unit of millimeter.
Maximum diameter of internal jugular vein (Dmax) change
时间窗: Dmax will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Dmax will be measured as a unit of millimeter
Minimum diameter of internal jugular vein (Dmin) change
时间窗: Dmin will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
Dmin will be measured as a unit of millimeter
Internal jugular vein collapsibility index (IJV-CI) change
时间窗: IJV-CI will be measured before the block (basal) and it will be measured at 20th and 60th minutes after the block. The change between the measurements of basal and 60th minute, and change between basal and 20th minute will be assessed
IJV-CI will be measured as a unit of %.
次要结局
未报告次要终点
研究者
Oguz Gundogdu
Assistant Professor
Cumhuriyet University