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临床试验/NCT02326727
NCT02326727Unknown不适用

Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年4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
30
试验地点
1
主要终点
Count of live and dead target erythroleukemic cells

研究概览

简要总结

Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

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 undergoing colonic cancer surgery

排除标准

  • Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy

研究组 & 干预措施

General Anesthesia

Active Comparator

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

干预措施: Fentanyl (Drug)

General Anesthesia

Active Comparator

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

干预措施: Propofol (Drug)

General Anesthesia

Active Comparator

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

干预措施: Isoflurane (Drug)

General Anesthesia

Active Comparator

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

干预措施: Nitrous Oxide (Drug)

Combined anesthesia

Active Comparator

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

干预措施: Ropivacaine (Drug)

Combined anesthesia

Active Comparator

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

干预措施: Fentanyl (Drug)

Combined anesthesia

Active Comparator

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

干预措施: Propofol (Drug)

Combined anesthesia

Active Comparator

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

干预措施: Isoflurane (Drug)

Combined anesthesia

Active Comparator

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

干预措施: Nitrous Oxide (Drug)

结局指标

主要结局

Count of live and dead target erythroleukemic cells

时间窗: 72 hours

All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.

Plasma concentration of cytokines

时间窗: 72 hours

All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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