|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00311259 |
|
Date of registration:
|
03/04/2006 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
May 2006 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00311259 |
|
Study type:
|
Observational |
|
Study design:
|
Allocation: Random Sample, Time Perspective: Cross-Sectional
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Bülent Kücükakin |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte |
|
|
Name:
|
Bülent Kücükakin |
|
Address:
|
|
|
Telephone:
|
+45 39978224 |
|
Email:
|
bulkuc01@gentoftehosp.kbhamt.dk |
|
Affiliation:
|
|
|
|
Name:
|
Bülent Kücükakin |
|
Address:
|
|
|
Telephone:
|
+45 3997824 |
|
Email:
|
bulkuc01@gentoftehosp.kbhamt.dk |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Inflammatory Stress
|
|
Myocardial Ischaemia
|
|
Oxidative Stress
|
|
Intervention(s)
|
|
Drug: Laktose
|
|
Drug: Melatonin (drug)
|
|
Secondary ID(s)
|
|
2612-3108
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|