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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00311259
Enrollment
40
Registered
2006-04-05
Start date
2006-05-31
Completion date
2006-11-30
Last updated
2006-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Stress, Myocardial Ischaemia, Oxidative Stress

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.

Interventions

DRUGMelatonin (drug)
DRUGLaktose

Sponsors

University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Countries

Denmark

Contacts

Primary ContactBülent Kücükakin
bulkuc01@gentoftehosp.kbhamt.dk+45 39978224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026