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临床试验/NCT02037399
NCT02037399Unknown不适用

Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection

Yonsei University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年7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
50
试验地点
1
主要终点
present pain intensity (PPI)

研究概览

简要总结

Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.

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
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 20 years of age or older
  • pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
  • patients who gave written informed consent from patients or responsible family members.

排除标准

  • patients who take pain killer within 48 hours or regularly at enrollment
  • confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
  • multiple gastric lesions for ESD
  • history of gastric surgery at enrollment
  • severe underlying disease including infection, cardiopulmonary disease, and diabetes.

研究组 & 干预措施

intravenous dexamethasone

Experimental

To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD

干预措施: intravenous dexamethasone (Drug)

intravenous normal saline

Placebo Comparator

To receive normal saline as placebo intravenous immediately after ESD

干预措施: intravenous normal saline (Drug)

结局指标

主要结局

present pain intensity (PPI)

时间窗: at 6 hours after ESD

The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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