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临床试验/NCT02874378
NCT02874378Unknown不适用

Effects of Dexmedetomidine on Postoperative Renal Function Recovery After Kidney Transplantation in Adult Patients: Double-Blinded, Randomised Controlled Trial

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Cystatin C level

研究概览

简要总结

Postoperative renal function recovery is very important to value the operation quality after kidney transplantation. Dexmedetomidine is a selective alpha-2 agonist,enhances urine flow rate and perioperative renal function. Some animal experiments have revealed its beneficial effects against ischemia-reperfusion injury (IRI), our goal is therefore to investigate the effectiveness of a recipient treatment with Dexmedetomidine during operation at reducing Cystatin C level and enhancing renal function after kidney transplantation.

详细描述

Participants will be randomly assigned, in a 1:1 ratio, to receive Dexmedetomidine or control (0.9 %Sodium Chloride Solution,0.9%NaCl). The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center.Dexmedetomidine and 0.9 %NaCl solution will be treated from 10 minutes before anesthesia induction, ending in the last 10 minutes before the operation to complete. Cystatin C level and urine volume (but are not limited to these data) at 1,7,14 days after the transplantation will be recorded. The participation of each patient is scheduled for 14 days.Investigators will research both living and cadaveric kidney transplants.

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
Double (Participant, Care Provider)

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients underwent renal transplant in the First Affiliated Hospital of Xi'an Jiaotong University.

排除标准

  • severe comorbidity history: severe cardiac dysfunction, central nervous system disease, endocrine, and history of mental disorders; alcoholic and long-term use of sedatives and opioids history; drug allergy history.

研究组 & 干预措施

study group

Experimental

Dexmedetomidine will be pumped at 0.3μg/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients.

干预措施: Dexmedetomidine (Drug)

control group

Placebo Comparator

0.9%NaCl solution 0.1ml/kg•h during the operation till 30 minutes before the operation complete. Standard anaesthesia and standard cure are given for all patients.

干预措施: 0.9%NaCl solution (Drug)

结局指标

主要结局

Cystatin C level

时间窗: 2 weeks

次要结局

  • average daily urinary volume(2 weeks)
  • length of hospital stay (LOS)(an expected average of 2 weeks)
  • Wake up time, extubation time,SAS score,PONV(up to 6 hours)
  • total dosage of remifentanil(up to 4 hours)
  • Cr/GFR improvement(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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