Dyssomnias, Fatigue, Postoperative Complications
Conditions
Keywords
melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
Brief 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.
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.
Interventions
DRUGmelatonin
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Operation for gall bladder disease * Age over 18 years
Exclusion criteria
* Known preoperative sleep disturbance * Anticoagulant therapy * Psychiatric disease * Lack of written informed consent * Treatment with hypnotics within one week prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality | — |
| general wellbeing | — |
| pain | — |
Countries
Denmark
Outcome results
None listed