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

• Conditions: Oxidative Stress; Inflammatory Stress; Myocardial Ischaemia

• Registration Number: NCT00311259
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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, 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 Timeline

• Status Verified: 2006-02
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Last Update Submitted: 2006-04-03
• Study First Posted: 2006-04-05
• Last Update Posted: 2006-04-05
• Study Start: 2006-05
• Study Completion: 2006-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte; 🇩🇰 Hellerup, Denmark