Melatonin Treatment After Laparoscopic Cholecystectomy

Phase 2

Completed

• Conditions: Fatigue; Postoperative Complications; Dyssomnias

• Registration Number: NCT00113906
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Study Timeline

• Study Start: 2005-03
• Status Verified: 2005-06
• Study First Submitted: 2005-06-10
• Study First Submitted QC: 2005-06-10
• Study First Posted: 2005-06-13
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue

Secondary Outcome Measures

Name	Time	Method
Sleep quality
general wellbeing
pain

Trial Locations

Locations (2)

University Hospital of Glostrup; 🇩🇰 Glostrup, Copenhagen, Denmark

Copenhagen University Hospital, Gentofte; 🇩🇰 Hellerup, Copenhagen, Denmark