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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
  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:

Drug Information available for: Melatonin
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Gentofte, Copenhagen

Additional 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
Study First Received: April 3, 2006
Last Updated: April 3, 2006
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on May 23, 2013