Oxidative StressNCT00311259
Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
An observational study of Oxidative Stress and Inflammatory Stress, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammatory Stress, Myocardial Ischaemia
- What is being tested?
- Melatonin (drug) and Laktose
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- May 2006to Nov 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- indikation for laparoscopic cholecystectomy
- women between 18 and 70 years old
Who cannot join
- men
- acute cholecystectomy
- pancreatitis
- renal insufficient
- well-known liver insufficient
- cardiovascular disease (arrhythmia, well-known ischaemic heart disease)
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, 2900
Bülent Kücükakin, +45 3997824, bulkuc01@gentoftehosp.kbhamt.dk
About this study
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.
Read the 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.
- Conditions
- Oxidative Stress, Inflammatory Stress, Myocardial Ischaemia
- Being tested
- Melatonin (drug), Laktose
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin (drug)Drug
LaktoseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMay 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Bülent Kücükakin, Principal investigator, Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311259
- Sponsor's protocol ID
- 2612-3108
- Status last verified
- Feb 2006
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Publications
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.
PubMed 20887414
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Treatment and Inflammation, Oxidative Stress and Autonomic Function in Connection With Surgery
- ClinicalTrials.gov ID
- NCT00311259
- Acronym / sponsor ID
- 2612-3108
- Conditions
- Oxidative Stress, Inflammatory Stress, Myocardial Ischaemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Nov 2006
- First posted
- 5 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indikation for laparoscopic cholecystectomy
- women between 18 and 70 years old
Key exclusion criteria (15 listed)
- men
- acute cholecystectomy
- pancreatitis
- renal insufficient
- well-known liver insufficient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin (drug) | Drug | – |
| Laktose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2006.
- Derived from this study: PubMed 20887414Kucukakin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bülent Kücükakin principal investigator
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress and Inflammatory Stress, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bülent Kücükakin (+45 39978224, bulkuc01@gentoftehosp.kbhamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2006.