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临床试验/NCT05951842
NCT05951842撤回不适用

The Differences Between the Effects of Total Intravenous Anesthesia (TIVA) and Balanced Anesthesia on NK Cell and Cytokine Response in Colorectal Cancer Patients Undergoing Cytoreductive Surgery and HIPEC(Hyperthermic Intraperitoneal Chemotherapy)

Gangnam Severance Hospital0 个研究点开始时间: 2018年4月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Postoperative immune function (NK cell count)

研究概览

简要总结

Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.

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, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old)
  • American Society of Anesthesiologists physical status I, II, III

排除标准

  • Patients under 20 years old.
  • Patients with long-term steroid therapy or immunosuppressive therapy.
  • Patients with long-term NSAIDs therapy.
  • Patients who cannot communicate with other person or with cognitive disorder.
  • Patients who cannot read the consent form.

研究组 & 干预措施

TIVA group

Active Comparator

In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion.

Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea

干预措施: anesthetic method (Drug)

Balanced anesthesia group.

Experimental

Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.

Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,

干预措施: anesthetic method (Drug)

结局指标

主要结局

Postoperative immune function (NK cell count)

时间窗: Postoperative day 1

Postoperative immune function will be measured at baseline, POD#1, and POD#7. Postoperative immune function will be investigated by measuring NK cell count.

次要结局

未报告次要终点

研究者

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

Dong Woo Han

Professor

Gangnam Severance Hospital

相似试验

Anesthesia, TIVA, Balanced Anesthesia, NK Cell | 临床试验