Melatonin Treatment After Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00113906
Recruitment Status : Completed
First Posted : June 13, 2005
Last Update Posted : February 11, 2014
Information provided by:
University Hospital, Gentofte, Copenhagen

June 10, 2005
June 13, 2005
February 11, 2014
March 2005
August 2006   (Final data collection date for primary outcome measure)
Same as current
Complete list of historical versions of study NCT00113906 on Archive Site
  • Sleep quality
  • general wellbeing
  • pain
Same as current
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Melatonin Treatment After Laparoscopic Cholecystectomy
The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Postoperative Complications
  • Fatigue
  • Dyssomnias
Drug: melatonin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2006
August 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Ismail Gögenur, MD Copenhagen University Hospital, Gentofte
University Hospital, Gentofte, Copenhagen
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP