Melatonin Treatment and Inflammation, Oxidative Stress an... | NCT00311259

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

NCT00311259

Sponsor

University Hospital, Gentofte, Copenhagen

Status

Unknown status

Last Update Posted

Apr 5, 2006Estimated

Enrollment

Phase

Not provided

Conditions

Oxidative Stress
Inflammatory Stress
Myocardial Ischaemia

Interventions

Melatonin (drug)
Laktose

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006

First Submitted Date

Apr 3, 2006

First Submission Date that Met QC Criteria

Apr 3, 2006

First Posted Date

Apr 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2006

Last Update Posted Date

Apr 5, 2006Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bülent Kücükakin	Contact	+45 39978224		bulkuc01@gentoftehosp.kbhamt.dk

Overall Officials

Name	Affiliation	Role
Bülent Kücükakin	Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte		Hellerup		2900	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20887414	Derived	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.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D008550	Melatonin
D004364	Pharmaceutical Preparations

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Name	Type	Description	Arm Group Labels	Other Names
Melatonin (drug)	Drug
Laktose	Drug