Evaluation of Ischemia and Reperfusion Interval With Neuromonitorization in Tourniquet Application
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- MEP 50% reduction in intraoperative neuromonitorization
研究概览
简要总结
The goal of this clinical trial is to compare two differential tourniquet pressure in lower extremity surgery cases. The main questions it aims to answer are:
- What are the perioperative neurophysiological effects of ischemia and compression in the tissue under the tourniquet?
- Are the effects of two different tourniquet pressures on neuromonitoring significantly different?
- Can the ideal time of the reperfusion interval be evaluated by neuromonitoring?
- Are the effects of two different tourniquet pressures on the quadriceps denervation significantly different from each other? Participants meeting the inclusion criteria will be evaluated for parameters to be used preoperatively. It will be evaluated in the 1st day, 1st week and 1-month follow-ups in the postoperative period.
The investigators will compare two different tourniquet pressure ( Limb occlusion pressure +50 mmHg / + 100 mmHg) to see if it will be evaluated whether there is a significant difference in terms of quadriceps denervation, vas scores, total blood estimate volume loss, intraoperative MEP decrease, and recovery times, quadriceps tendon thickness, thigh circumfrences.
详细描述
As a result of the power analysis for this study, the number of samples was determined as 24. The study was started after the approval of the ethics committee.
Participants who met the inclusion and exclusion criteria were randomized in terms of tourniquet pressure to be applied and divided into two groups. It was planned to evaluate quadriceps tendon thickness by USG and MRI, thigh circumference, VAS scores, CBC, and CK in blood samples in the preoperative period of all patients. It was planned to obtain parameters related to MEP by using intraoperative neuromonitorization during the surgery. In the postoperative period, all parameters that were evaluated preoperatively on the 1st day, 1st week, and 1st month were re-evaluated. Finally, EMG evaluation was planned for 1 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operation planning in the foot and ankle area
排除标准
- •Having a history of previous foot and ankle surgery,
- •Having a history of previous knee surgery or spinal surgery,
- •Diagnosis of diabetes mellitus,
- •Having a known diagnosis of a disease affecting the peripheral nervous system (peripheral neuropathy, previous spinal surgery, stroke, etc.),
- •Having a diagnosis of a disease affecting the known peripheral vascular system (Peripheral vascular disease, calcified popliteal artery, peripheral arterial bypass surgery, vasculitis, advanced chronic venous insufficiency),
- •Having a disease that affects the ideal tourniquet application (Chronic Lymphedema, BMI>35, Stage 3 and above chronic renal failure, uncontrollable hypertension),
- •Having been diagnosed with a known coagulation disorder,
- •History of pulmonary embolism or deep vein thrombosis.
- •ASA score above 3
- •Surgery time to be less than 80 minutes
结局指标
主要结局
MEP 50% reduction in intraoperative neuromonitorization
时间窗: Intraoperative
Time with more than 50% reduction in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
MEP full recovery intraoperative neuromonitorization
时间窗: Intraoperative
Time with full recovery in perioperative MEP will be compared in groups in which two different tourniquet pressures were applied.
次要结局
- Quadriceps Tendon Thickness-USG(Preoperative, Postoperative 1st day and 4th week will be evaluated)
- CK levels(Preoperative, Postoperative 1st day, Postoperative 1 st month)
- Quadriceps Tendon Thickness-MRI(Preoperative, Postoperative third month)
- Total Blood Estimate Volume Loss(Preoperative, Postoperative 1st day)
- EMG(Postoperative 1 st month)
- Thigh Diameter(Preoperative, Postoperative 1st day, first week and 4th week will be evaluated)
- Surgical Area Pain(Preoperative, Postoperative 1st day, Postoperative 1 st month)
研究者
AHMET MUCTEBA YILDIRIM
Principal Investigator, MD
Istanbul University