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临床试验/NCT00311259
NCT00311259Unknown不适用

Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery

University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年5月最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1

研究概览

简要总结

The purpose of this study is to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

详细描述

Laparoscopic gall bladder surgery is connected with changes in the body resulting in cell damage and inflammation. Melatonin is a hormone produced in brain and regulate sleep rhythm, temperature, production of other hormones and function of organs. Furthermore melatonin can modify cell damage and inflammation. After surgery the production of melatonin is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation in connection with laparoscopic gall bladder surgery.

研究设计

研究类型
Observational
时间视角
Other

入排标准

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

入选标准

  • indikation for laparoscopic cholecystectomy
  • women between 18 and 70 years old

排除标准

  • acute cholecystectomy
  • pancreatitis
  • renal insufficient
  • well-known liver insufficient
  • cardiovascular disease (arrhythmia, well-known ischaemic heart disease)
  • drug therapy (digoxin, Ca-antagonist, amiodaron, beta-blocker)
  • anticoagulation therapy (marevan and marcoumar)
  • praeoperative therapy with opioid, anxiolytica and hypnotica)
  • well-known sleep disease
  • endocrine disease in drug therapy (diabetes mellitus, thyroid disease)
  • daily alcohol consumption (more than 5 drinks)
  • bad compliance (language difficulty, mental problems etc.)
  • pregnancy and breast-feeding
  • lack of written consent

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other

研究点 (1)

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