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

NCT ID: NCT00311259

Last Updated: 2006-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Oxidative Stress Inflammatory Stress Myocardial Ischaemia

Study Design

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Study Time Perspective

OTHER

Interventions

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Melatonin (drug)

Intervention Type DRUG

Laktose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Bülent Kücükakin

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Locations

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Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Bülent Kücükakin

Role: CONTACT

[email protected]
+45 39978224

Facility Contacts

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Bülent Kücükakin

Role: primary

[email protected]
+45 3997824

References

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Kucukakin B, Klein M, Lykkesfeldt J, Reiter RJ, Rosenberg J, Gogenur I. No effect of melatonin on oxidative stress after laparoscopic cholecystectomy: a randomized placebo-controlled trial. Acta Anaesthesiol Scand. 2010 Oct;54(9):1121-7. doi: 10.1111/j.1399-6576.2010.02294.x.

Reference Type DERIVED
PMID: 20887414 (View on PubMed)

Other Identifiers

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2612-3108

Identifier Type: -

Identifier Source: org_study_id