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临床试验/NCT02235246
NCT02235246已完成4 期

The Effect of Perioperative Intravenous Magnesium on Pain After Endoscopic Submucosal Dissection for Gastric Neoplasm: Prospective Randomized Double-blind Placebo Controlled Study

Yonsei University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
pain score

研究概览

简要总结

Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer or premalignant lesions in the stomach. ESD enables en bloc resection of gastrointestinal neoplasms, increases the rates of histologically complete resections, and also reduces local recurrence rates. Despite these advantages, ESD is thought to induce various complications. Wellknown ESD-related complications include perforation, postoperative bleeding, or stricture. In addition, minor adverse events after ESD are also commonly noticed. Pain is one of these frequently noticed minor ESD related complications, is the main reason for prolongation of the hospital stay, and is related to patients' compliance; however, there is a tendency to neglect or underestimate post-ESD pain. The causes of pain associated with ESD are thought to be associated with transmural burn or transmural air leak. Some studies have tried to control localized pain during and after ESD using local lidocaine, single dose postoperative intravenous dexamethasone or a transdermal fentanyl patch. Magnesium has been reported to alter the perception and duration of pain and produce important analgesic effects. It is included the suppression of neuropathic pain, potentiation of morphine analgesia, and attenuation of morphine tolerance. Although the exact mechanism is not yet fully understood, the analgesic properties of magnesium are believed to stem from regulation of calcium influx into the cell and antagonism of N-methyl-D-aspartate receptors in the central nervous system. Also, magnesium may prolong neuromuscular blockade after administration of neuromuscular blocking drugs, increase sedation and contribute to serious cardiac morbidity. And magnesium as a hypotensive anaesthesia technique supply objectively better operative field, reduction in the duration of surgery and reduced blood loss. There have been no previous trials on the use of magnesium specifically for pain control following ESD. Thus, the purpose of this study was to assess the efficacy of intravenous magnesium 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
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • age of 40- 80 years

排除标准

  • patients who cannot read,
  • patients refusing the study
  • allergy to magnesium
  • chronic pain
  • chronic abuse of opioid or NSAID
  • neuromuscular block
  • atrioventricular conductance block
  • liver failure,

研究组 & 干预措施

normal saline

Experimental

干预措施: Normal saline (Drug)

magnesium sulfate

Active Comparator

干预措施: Magnesium Sulfate (Drug)

结局指标

主要结局

pain score

时间窗: average 24hours from endoscopic processure

Pain score related with endoscopic mucosal resection will be evaluated with numerical rating scale (0 \~ 10) at time of 30 min, 1 hr, 6 hr, and 24 hr after procedure end.

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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