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临床试验/NCT02559297
NCT02559297已完成2 期

Effects of Sevoflurane and Desflurane Anesthesia on Regulatory T Cells in Patients Undergoing Living Donor Kidney Transplantation

Mahidol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年8月10日最近更新:
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
40
试验地点
1
主要终点
Number of regulatory T cells

研究概览

简要总结

This prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory T cell (Treg) numbers and its cytokine production in patients undergoing Living Donor Kidney Transplant (LDKT).

详细描述

All patients with end stage renal disease (ESRD) need renal replacement therapy, either dialysis or kidney transplantation. Dialysis, despite its effectiveness in prolonging ESRD patients' lives, is a burden. Successfulness in kidney transplantation will restore good quality of life in ESRD patients. However, one of the most important complications that lead to transplant failure is graft rejection. It is already known that the pathophysiology of the rejection is immune response. Recent evidence showed that regulatory T cell (Treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). Characterization of Treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection.

Kidney transplantation is conducted under general anesthesia. Interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). Although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on Treg function has totally been unknown. Knowing the effects of inhalation agents on Treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patients receiving 1st living donor kidney transplantation

排除标准

  • Hyperacute graft rejection
  • Pre-existing autoimmune or immunodeficiency diseases in recipients
  • Receiving blood product during 24-h perioperative period
  • Patient refuse to participate this study at any time point

研究组 & 干预措施

Sevoflurane

Active Comparator

In sevoflurane arm (n=20) at the beginning after successful intubation, 2 L/min nitric oxide (N2O), 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O.

干预措施: Sevoflurane (Drug)

Desflurane

Experimental

In desflurane arm (n=20) at the beginning after successful intubation, 2 L/min N2O, 2 L/min O2, and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 MAC of desflurane in 50% O2 and 50% N2O.

干预措施: Desflurane (Drug)

结局指标

主要结局

Number of regulatory T cells

时间窗: Within 24-h peri-operative period

Assessing change of Treg numbers by flow cytometry from baseline (before exposure to sevoflurane or desflurane) to after exposure to sevoflurane or desflurane for 2-h and 24-h

次要结局

  • T lymphocyte cytokine production(Within 24-h peri-operative period)

研究者

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

Arpa Chutipongtanate

Faculty Member

Mahidol University

研究点 (1)

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