Melatonin Treatment After Laparoscopic Cholecystectomy

Status Completed

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00113906
Study type	Interventional
Source	University Hospital, Gentofte, Copenhagen
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	March 2005
Completion date	August 2006

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