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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2006 by University Hospital, Gentofte, Copenhagen.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311259
First Posted: April 5, 2006
Last Update Posted: April 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Gentofte, Copenhagen
  Purpose
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.

Condition Intervention Phase
Oxidative Stress Inflammatory Stress Myocardial Ischaemia Drug: Melatonin (drug) Drug: Laktose Phase 2

Study Type: Observational
Study Design: Allocation: Random Sample
Time Perspective: Cross-Sectional
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Estimated Enrollment: 40
Study Start Date: May 2006
Estimated Study Completion Date: November 2006
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311259


Contacts
Contact: Bülent Kücükakin +45 39978224 bulkuc01@gentoftehosp.kbhamt.dk

Locations
Denmark
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte Not yet recruiting
Hellerup, Denmark, 2900
Contact: Bülent Kücükakin    +45 3997824    bulkuc01@gentoftehosp.kbhamt.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Bülent Kücükakin Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00311259     History of Changes
Other Study ID Numbers: 2612-3108
First Submitted: April 3, 2006
First Posted: April 5, 2006
Last Update Posted: April 5, 2006
Last Verified: February 2006

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants