Melatonin Treatment After Laparoscopic Cholecystectomy

Fatigue Clinical Trial

Official title:

The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113906
• Other study ID #: 2004-003796-37
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 10, 2005
• Last updated: February 10, 2014
• Start date: March 2005
• Est. completion date: August 2006

Study information

• Verified date: June 2005
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dyssomnias
• Fatigue
• Postoperative Complications

Intervention

Drug:
• melatonin

Locations

Country	Name	City	State
Denmark	University Hospital of Glostrup	Glostrup	Copenhagen
Denmark	Copenhagen University Hospital, Gentofte	Hellerup	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue
Secondary	Sleep quality
Secondary	general wellbeing
Secondary	pain