Postoperative ComplicationsPhase 2/3NCT00113906
Melatonin Treatment After Laparoscopic Cholecystectomy
A Phase 2/3 study testing melatonin in people with Postoperative Complications and Fatigue, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial summary
Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Fatigue, Dyssomnias
- What is being tested?
- melatonin
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2005to Aug 2006
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operation for gall bladder disease
- Age over 18 years
Who cannot join
- Known preoperative sleep disturbance
- Anticoagulant therapy
- Psychiatric disease
- Lack of written informed consent
- Treatment with hypnotics within one week prior to surgery
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
University Hospital of Glostrup
Glostrup Municipality, Copenhagen, 2900
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, 2900
About this study
Official title: The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.
Read the detailed description
Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.
- Conditions
- Postoperative Complications, Fatigue, Dyssomnias
- Being tested
- melatonin
- Keywords
- melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
- Medical subject headings
- Postoperative Complications, Fatigue, Dyssomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Secondary outcomes (3)
Sleep quality
general wellbeing
pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2005 (estimated)
- Study startMar 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Ismail Gögenur, MD, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113906
- Sponsor's protocol ID
- 2004-003796-37
- Other IDs
- 2004
- Status last verified
- Jun 2005
- First submitted
- 10 Jun 2005
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00113906
- Acronym / sponsor ID
- 2004-003796-37
- Conditions
- Postoperative Complications, Fatigue, Dyssomnias
- Keywords
- melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Jun 2005 (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.
Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.
Detailed description
Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operation for gall bladder disease
- Age over 18 years
Key exclusion criteria (5 listed)
- Known preoperative sleep disturbance
- Anticoagulant therapy
- Psychiatric disease
- Lack of written informed consent
- Treatment with hypnotics within one week prior to surgery
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 | – |
Primary outcome
Fatigue
3 secondary outcomes
Sleep quality
general wellbeing
pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
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Tramadol Versus Morphine for Postoperative Pain Relief Following Laparoscopic Abdominal Surgery
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Not yet recruitingObservational study
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The Mepilex Cesarean Delivery Trial / MEPIDEL
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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.
Ismail Gögenur, MD principal investigator
University Hospital, Gentofte, Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing melatonin in people with Postoperative Complications and Fatigue, run by University Hospital, Gentofte, Copenhagen at 2 sites 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 5 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: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2014.