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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melatonin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality | ||
| general wellbeing | ||
| pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismail Gögenur, MD | University Hospital, Gentofte, Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Glostrup | Glostrup Municipality | Copenhagen | 2900 | Denmark | ||
| Copenhagen University Hospital, Gentofte |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D005221 | Fatigue |
| D020920 | Dyssomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Hellerup |
| Copenhagen |
| 2900 |
| Denmark |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |