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NCT00311259 Clinical Trial

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

Oxidative Stress Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00311259
Other study ID # 2612-3108
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received April 3, 2006
Last updated April 3, 2006
Start date May 2006
Est. completion date November 2006

Study information
Verified date February 2006
Source University Hospital, Gentofte, Copenhagen
Contact Bülent Kücükakin
Phone +45 39978224
Email bulkuc01@gentoftehosp.kbhamt.dk
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Random Sample, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Drug:
• Melatonin (drug)

• Laktose

Locations
Country Name City State
Denmark Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte Hellerup

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

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