Melatonin Treatment After Laparoscopic Cholecystectomy

University Hospital, Gentofte, Copenhagen200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Postoperative Complications Fatigue Dyssomnias

Interventions

melatoninDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

University Hospital of Glostrup

Glostrup Municipality, Copenhagen, Denmark

Copenhagen University Hospital, Gentofte

Hellerup, Copenhagen, Denmark

Outcomes

Primary Outcomes

Fatigue

Secondary Outcomes

Sleep quality

general wellbeing

pain

Data from ClinicalTrials.gov

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