Melatonin Treatment After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00113906
First received: June 10, 2005
Last updated: February 10, 2014
Last verified: June 2005

June 10, 2005
February 10, 2014
March 2005
August 2006   (final data collection date for primary outcome measure)
Fatigue
Same as current
Complete list of historical versions of study NCT00113906 on ClinicalTrials.gov Archive Site
  • Sleep quality
  • general wellbeing
  • pain
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Postoperative Complications
  • Fatigue
  • Dyssomnias
Drug: melatonin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00113906
2004-003796-37
Yes
Not Provided
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