Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- total oxidant status
研究概览
简要总结
The application of tourniquet is indispensable for a bloodless surgical area in total knee arthroplasty surgery. The release of tourniquet produces reactive oxygen species which can cause injury and then ischemia-reperfusion injury emerge. Our aim in this study is to investigate effects of pregabalin, GABA analog drug, on the tourniquet induced ischemia-reperfusion injury.
详细描述
Investigators will randomize patients into two groups. 1) Pregabalin group 2) Control group.
Investigators will give orally pregabalin 150 mg to the pregabalin group patients two times (first dose 1 day before surgery., second dose 1 hour before surgery). On the other hand placebo drug will give to the control group at the same times. Investigators will perform combined spinal epidural anesthesia for surgery and inject 3 cc 0.5% hyperbaric bupivacaine to subarachnoid space. Investigators will take blood samples for measurement of ischemia-reperfusion determinants, immediately before surgery, shortly before tourniquet deflation, and 20 minutes after tourniquet deflation. Then these samples will be analysed by ELISA method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Undergoing a total knee arthroplasty surgery
- •Accept neuroaxial anesthesia for surgery
排除标准
- •Any antiepileptic drug use
- •Allergic reaction to pregabalin
- •Severe hepatic, renal or gastrointestinal disorders
- •Psychiatric disorders
- •Pregnant women or breastfeeding
- •NSAID or opioid drug use for a long time
- •Diabetic or other neuropathic pain
研究组 & 干预措施
Pregabalin Group
We will give 150 mg pregabalin capsule orally 1 day before surgery and 1 hour before surgery (totally two times) to the pregabalin group patients.
干预措施: Pragabalin (Drug)
Control Group
In control group, we will empty the drug material from capsules and give only empty capsules to the control group patients at the same times.
干预措施: Placebo (Other)
结局指标
主要结局
total oxidant status
时间窗: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total oxidant status
total antioxidant status
时间窗: before tournique application, just before tournique release, 20 minutes after tournique release
changes of total antioxidant status
ischemia modified albumin
时间窗: before tournique application,just before tournique release, 20 minutes after tournique release
changes of ischemia modified albumin
次要结局
- catalase(before tournique application, just before tournique release, 20 minutes after tournique release)
研究者
Omer Karaca
Assistant Professor
Baskent University