Comparison of Effects of Combined Spinoepidural and General Anesthesia Effects on Incidence of Postoperative Complications Following Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Death
研究概览
简要总结
The aim of this study is to investigate the effect of combined spinoepidural and general anesthesia on the incidence of postoperative complications following total knee arthroplasty
详细描述
Total knee arthroplasty is known to cause complications (pulmonary thromboembolism, acute kidney injury, arryhthmias and infection). The investigators aimed to study the effects of two different anesthesia techniques, i.e. combined spinoepidural anesthesia and general anesthesia on the incidence of postoperative complications such as arrhythmia, pulmonary thrombeoembolism, infection, acute kidney injury and mortality.
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 (Outcomes Assessor)
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
- •Patients scheduled to undergo elective unilateral total knee arthroplasty
排除标准
- •Patient refusal
- •Scheduled for bilateral or unilateral unicondylar knee arthroplasty
- •Known history of allergy to drugs used in the study
- •Severe systemic disease
- •Morbid obesity (BMI>30)
- •History of renal dysfunction
研究组 & 干预措施
General Anesthesia
The patients in this group will undergo unilateral total knee arthroplasty under general anesthesia. Following vascular access and monitorization (non-invasive blood pressure, saturation, electrocardiography).
Epidural chateterisation will be performed and test dose will be applied. Induction will be carried out using propofol (3mg/kg), fentanyl (1cmg/kg) and rocuronium (0.6 mg/kg). Maintenance will be carried out using sevoflurane (%2-3) and 50-50% mixture of nitrous oxide and oxygen. Epidural analgesia will be initiated after the end surgery.
干预措施: General Anesthesia (Other)
Regional Anesthesia
The patients in this group will undergo unilateral total knee arthroplasty under combined spinoedpidural anesthesia . Following vascular access and monitorization (noninvasive blood pressure, oxygen saturation and electrocardiography), spinal anesthesia will be performed using 12,5 mg marcaine given to the subarachnoid space and epidural analgesia will be initiated at the end of surgery following negative test dose. The patients will be given nasal oxygen supplementation.
干预措施: Regional Anesthesia (Other)
结局指标
主要结局
Death
时间窗: Postoperative sixth week
Number of participants with mortality
Pulmonary Thromboembolism
时间窗: Postoperative sixth week
Number of participants with new onset pulmonary thromboembolism
Infection
时间窗: Postoperative sixth week
Number of participants with new onset infection
Arryhthmia
时间窗: Postoperative sixth week
Number of participants with new onset arryhthmia requiring treatment
Acute Kidney Injury
时间窗: Postoperative sixth week
Number of participants with new onset acute kidney injury
次要结局
未报告次要终点
研究者
Perihan Ekmekçi
Primary Investigator
Ufuk University