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临床试验/NCT01902849
NCT01902849已完成不适用

The Influence of Anesthetic Technique on Interleukin Plasma Level in Colorectal Cancer Surgery - TIVA vs Inhalation Anesthesia

Iuliu Hatieganu University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
measurement of interleukins IL6 and IL10 plasmatic level

研究概览

简要总结

Knowing the fact that the anesthetic substances can alter the immune response during the surgery, the purpose of the study is to evaluate the influence of two general anesthetic techniques - inhalation vs. total intravenous anesthesia on the immune response in patient with colorectal surgery for neoplastic disease, evaluated by the plasma level of the interleukins 6 and 10(IL6, IL10).

详细描述

Introduction

Several factors are contributing to perioperative immunosuppression such as: surgery itself, general anesthesia. In vivo and in vitro studies have shown that anesthesia itself may alter the immune response either by direct effect on immune cells (such as natural killer and T helper) ) or indirectly by the influence of anesthetic substances on pro (IL-1, IL-6, tumor necrosis factor alpha ) and anti-inflammatory ( IL-4, IL-10) cytokines release.

The study aims to evaluate the influence of two general anesthetic techniques inhalation versus total intravenous anesthesia- target controlled infusion (TIVA-TCI) on the immune response in patient with colorectal surgery for neoplastic disease, evaluated by the plasma level of the interleukins IL6, IL10.

Study group:

  • patients admitted to the Surgical Clinic of the Regional Institute of Gastroenterology and Hepatology Prof Dr Octavian Fodor, undergoing open surgery for colorectal cancer (right/left colectomy, colorectal resection).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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 over 18 years with ASA physical status I-III.
  • colorectal cancer patients with no sign of local invasion (adjacent organs) and distant metastasis revealed by imaging studies
  • surgery performed by the same surgical team

排除标准

  • ASA physical status IV patients
  • hepatic and renal impairment
  • diabetes or other endocrine disorders
  • obesity (BMI 30 kg/m2)
  • immune disorders or immunosuppressive therapy
  • steroid treatment in the last 6 months

结局指标

主要结局

measurement of interleukins IL6 and IL10 plasmatic level

时间窗: 2 hours postoperatively (T2)

measurement of interleukins IL6 and IL 10 plasmatic level

时间窗: 24 hours postoperatively (T3)

measurement of interleukins IL6, IL10 plasmatic level

时间窗: after anesthesia induction but before surgical incision (T1)

* in group I (TIVA-TCI) when plasma concentration of propofol is 3-3.5 micrograms/ml * in group II (ISOFLURANE) when concentration of isoflurane in exhaled gases (Et iso) is between 0.3-0.5 %

次要结局

  • total opioid analgesic dose (mg)(for the first 24 hours postoperatively)

研究者

发起方
Iuliu Hatieganu University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Margarit Simona

senior lecturer, consultant in anesthesia and intensive care

Iuliu Hatieganu University of Medicine and Pharmacy

研究点 (1)

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