Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
April 3, 2006 updated by: University Hospital, Gentofte, Copenhagen
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Observational
Enrollment
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hellerup, Denmark, 2900
- Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bülent Kücükakin, Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion
November 1, 2006
Study Registration Dates
First Submitted
April 3, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 5, 2006
Study Record Updates
Last Update Posted (Estimate)
April 5, 2006
Last Update Submitted That Met QC Criteria
April 3, 2006
Last Verified
February 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2612-3108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.