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临床试验/NCT03373266
NCT03373266已完成2 期

Implication of Serum Fluoride Level Caused by Sevoflurane Versus Isoflurane Anesthesia Upon Renal Function After Kidney Transplantation.

Assiut University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Serum fluoride

研究概览

简要总结

Our primary goal is to investigate any hidden burden upon the grafted kidney from the increase of serum fluoride resulted from sevoflurane, versus isoflurane.

详细描述

Eighty patients with end stage renal failure undergoing living donor kidney transplant under general anesthesia were included in this study, by using an open (non-blinded) study design, patients were randomly assigned to two groups, 15 patients in each. Randomization was done through computer generated random tables. Isoflurane group; anesthesia was maintained with isoflurane 1-2%. Sevoflurane group; anesthesia was maintained with Sevoflurane 1-2%.

A peripheral intravenous access was secured in the hand opposite to the functioning fistula and induction of anesthesia was done with propofol 2mg/kg, neuromuscular blockade was maintained with atracurium 0.6mg/kg and all patients were intubated and ventilated to maintain end-tidal carbon dioxide (ETCO2) concentration between 30-40 mmHg. Anaesthesia was maintained with 1-2% isoflurane (isoflurane group) or 1-2% sevoflurane (sevoflurane group) with fresh gas flow of 2 L/min. In both groups inhalational anesthetic was delivered in an air-oxygen mixture of 1:1 ratio. Analgesia was maintained with fentanyl 1µg/kg/hr. Mannitol and sodium bicarbonate was given immediately before reperfusion (de-clamping of renal artery). Intraoperative monitoring included heart rate, noninvasive blood pressure, oxygen saturation, ETCO2, ECG and central venous line was placed in the right or left internal jugular vein depending upon the presence of dialysis catheter. Hemodynamic target include: mean arterial pressure of > 80mmHg, CVP between 10-15 mm Hg to optimize cardiac output and renal blood flow.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •end stage renal disease

排除标准

  • 未提供

研究组 & 干预措施

isoflurane

Active Comparator

anesthesia was maintained with isoflurane 1-2%.

干预措施: Isoflurane (Drug)

Sevoflurane

Active Comparator

anesthesia was maintained with Sevoflurane 1-2%.

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Serum fluoride

时间窗: 48 hours postoperative

Serum inorganic fluoride

serum fluoride

时间窗: 6 hours postoperative

Serum inorganic fluoride

次要结局

  • Serum creatinine(one week postoperative)
  • creatinine clearance(one week postoperative)
  • Urine output(48hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrady S Ibrahim, MD

Assistant professor

Assiut University

研究点 (1)

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