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

This study is not yet open for participant recruitment.

Verified by University Hospital, Gentofte, Copenhagen, February 2006

First Received: April 3, 2006 No Changes Posted

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00311259

Purpose

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.

Condition	Intervention	Phase
Oxidative Stress Inflammatory Stress Myocardial Ischaemia	Drug: Melatonin (drug) Drug: Laktose	Phase II

MedlinePlus related topics: Surgery

Drug Information available for: Melatonin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cross-Sectional, Random Sample, Prospective Study

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Study Completion Date:	November 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311259

Contacts

Contact: Bülent Kücükakin

+45 39978224

bulkuc01@gentoftehosp.kbhamt.dk

Locations

Denmark
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

Principal Investigator:

Bülent Kücükakin

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

More Information

No publications provided

Study ID Numbers:	2612-3108
Study First Received:	April 3, 2006
Last Updated:	April 3, 2006
ClinicalTrials.gov Identifier:	NCT00311259 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Antioxidants
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Depressants

Stress
Melatonin
Ischemia
Inflammation

Additional relevant MeSH terms:

Antioxidants
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Stress
Central Nervous System Depressants

Ischemia
Protective Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Melatonin
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009