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临床试验/NCT03514550
NCT03514550已完成4 期

Immunomodulatory Effects of Volatile and Total Intravenous Anesthesia for Patients With Renal Cancer

Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
CD 16

研究概览

简要总结

The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.

详细描述

The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.

研究设计

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

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

  • Surgery for renal cancer
  • Signed informed concent

排除标准

  • Propofol or sevoflurane intolerance
  • Contraindications for epidural anesthesia
  • Renal failure
  • Hepatic failure
  • Congestive heart failure
  • Previous hemotherapy
  • Hematological diseases

研究组 & 干预措施

total intravenous anesthesia

Experimental

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia

干预措施: Propofol (Drug)

total intravenous anesthesia

Experimental

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and propofol for perioperative anesthesia

干预措施: Epidural block (Procedure)

Volatile anesthesia

Active Comparator

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia

干预措施: Sevoflurane (Drug)

Volatile anesthesia

Active Comparator

Patients, scheduled for nephrectomy for kidney cancer will receive neuraxial epidural block and sevoflurane for perioperative anesthesia

干预措施: Epidural block (Procedure)

结局指标

主要结局

CD 16

时间窗: postoperative day 1

NK cells expression of CD16 receptor

次要结局

  • CD19(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD45(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD3(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD4(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD8(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD25(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • CD16(Baseline, end of surgery, postoperative days 1, 3-4, 7)
  • HLA-DR(Baseline, end of surgery, postoperative days 1, 3-4, 7)

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Principal Investigator
主要研究者

Efremov Sergey

Principal investigator

Meshalkin Research Institute of Pathology of Circulation

研究点 (1)

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