Status:
UNKNOWN
Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Oxidative Stress
Inflammatory Stress
Eligibility:
FEMALE
18-70 years
Brief Summary
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.
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, prod...
Eligibility Criteria
Inclusion
- indikation for laparoscopic cholecystectomy
- women between 18 and 70 years old
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
End Date :
November 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00311259
Start Date
May 1 2006
End Date
November 1 2006
Last Update
April 5 2006
Active Locations (1)
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1
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, Denmark, 2900