Melatonin Treatment After Laparoscopic Cholecystectomy

This study is currently recruiting participants.

Verified by University Hospital, Gentofte, Copenhagen, June 2005

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00113906

Purpose

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.

Condition	Intervention	Phase
Postoperative Complications Fatigue Dyssomnias	Drug: melatonin	Phase II Phase III

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Melatonin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

Fatigue

Secondary Outcome Measures:

Sleep quality
general wellbeing
pain

Estimated Enrollment:	200
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2006

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 3 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113906

Locations

Denmark, Copenhagen
University Hospital of Glostrup	Recruiting
Glostrup, Copenhagen, Denmark, 2900
Contact: Viggo Kristiansen, Chief of surgery +45 4323 2300 ext 404 vigkri01@glostruphosp.kbhamt.dk
Contact: ismail Gögenur, MD +45 3977 3390 ismgog01@gentoftehosp.kbhamt.dk
Principal Investigator: Ismail Gögenur, MD
Copenhagen University Hospital, Gentofte	Recruiting
Hellerup, Copenhagen, Denmark, 2900
Contact: Ismail Gögenur, MD +4539773390 ismgog01@gentoftehosp.kbhamt.dk
Principal Investigator: Ismail Gögenur, MD

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

Principal Investigator:

Ismail Gögenur, MD

Copenhagen University Hospital, Gentofte

More Information

Study ID Numbers:	2004-003796-37
Study First Received:	June 10, 2005
Last Updated:	April 3, 2006
ClinicalTrials.gov Identifier:	NCT00113906
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:

melatonin,
fatigue,
sleep quality,
circadian,

postoperative
Postoperative fatigue
postoperative sleep disturbance
general wellbeing

Study placed in the following topic categories:

Signs and Symptoms
Fatigue
Postoperative Complications
Mental Disorders

Dyssomnias
Sleep Disorders
Melatonin

Additional relevant MeSH terms:

Antioxidants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
Protective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009