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临床试验/NCT01870011
NCT01870011已完成4 期

A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
6
试验地点
1
主要终点
The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)

研究概览

简要总结

Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R injury and maintaining renal function during renal transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both kidney donors and recipients during deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation

排除标准

  • Donor exclusion criteria:
  • (1) Refusal of legal guardian
  • Recipient exclusion criteria:
  • Patient refusal
  • Hypersensitivity to propofol, soybeans or peanuts
  • History of vitamin C or E intake within 5 days before surgery
  • History of acute myocardial infarct within 6 months before surgery
  • Congestive heart failure (NYHA III-IV)
  • Autoimmune disease patients
  • BMI over 30 kg/m2
  • Left ventricular ejection fraction less than 35% upon preoperative echocardiography

研究组 & 干预措施

Desflurane balanced anesthesia group

Experimental

干预措施: Desflurane balanced anesthesia (Drug)

Propofol total intravenous anesthesia group

Active Comparator

干预措施: Propofol total intravenous anesthesia (Drug)

结局指标

主要结局

The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)

时间窗: Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction

1. Kidney donor: Inflammatory markers are evaluated immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction 2. Kidney recipient: (1) Inflammatory markers: Immediately after anesthesia induction, 2 and 24 hours after reperfusion (2) Renal function markers: Before anesthesia, 2 hours after reperfusion, immediate post-op, 24 and 48 hours postoperatively

次要结局

  • The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)(immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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