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临床试验/NCT04772794
NCT04772794Unknown不适用

Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
changes in serum level of interlukin 6

研究概览

简要总结

During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.

详细描述

During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.A striking conundrum is evident immediately when one review studies on the effects of oxygen on cytokines synthesis. Most investigators have found that hyperoxia enhances proinflammtory cytokines transcription and translations (11). In contrast, hyperparic oxygen has generally been shown to suppress stimulus induced porinflammtory cytokine production (12). Other studies have demonstrated that supplemental oxygen improves inflammatory and immune function (13), and it is not associated with clinically important side effect (14). We therefor undertook the current prospective randomized study to investigate whether perioperative supplemental oxygen (30% versus 80%) on pro and anti-inflammatory response in patients undergoing major abdominal cancer surgeries as our primary outcome.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • candidates for abdominal cancer surgeries

排除标准

  • Patients with chronic diseases, such as chronic obstructive pulmonary disease or pneumonia,
  • body mass index (BMI) >35 kg/m2,
  • severe malnutrition (albumin <3),
  • leukopenia (white blood cell <4,000 g/dL),
  • surgery within the previous 30 days and
  • O2 saturation < 90%, as measured using a pulse oximeter

结局指标

主要结局

changes in serum level of interlukin 6

时间窗: before operation (0), 1st, 3rd, and 7th days postoperative

serum level of interlukin 6 will be measured by ELISA technique

changes in serum level of interlukin 10

时间窗: before operation (0), 1st, 3rd, and 7th days postoperative

serum level of interlukin 6 will be measured by ELISA technique

次要结局

  • changes in total WBCs count(before operation (0), 1st, 3rd, and 7th days postoperative)

研究者

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

Shereen Mamdouh

Associate Professor

Assiut University

研究点 (2)

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