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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00311259
First received: April 3, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted

April 3, 2006
April 3, 2006
May 2006
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No Changes Posted
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Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
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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.

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.
Observational
Allocation: Random Sample
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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  • Oxidative Stress
  • Inflammatory Stress
  • Myocardial Ischaemia
  • Drug: Melatonin (drug)
  • Drug: Laktose
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Kücükakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gögenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
November 2006
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Inclusion Criteria:

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

Exclusion Criteria:

  • men
  • 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
Female
18 Years to 70 Years
Yes
Contact: Bülent Kücükakin +45 39978224 bulkuc01@gentoftehosp.kbhamt.dk
Denmark
 
NCT00311259
2612-3108
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University Hospital, Gentofte, Copenhagen
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Principal Investigator: Bülent Kücükakin Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
University Hospital, Gentofte, Copenhagen
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP