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Melatonin Treatment After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00113906
Recruitment Status : Completed
First Posted : June 13, 2005
Last Update Posted : February 11, 2014
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Postoperative Complications Fatigue Dyssomnias Drug: melatonin Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
Study Start Date : March 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Melatonin
U.S. FDA Resources




Primary Outcome Measures :
  1. Fatigue

Secondary Outcome Measures :
  1. Sleep quality
  2. general wellbeing
  3. pain


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113906


Locations
Denmark
University Hospital of Glostrup
Glostrup, Copenhagen, Denmark, 2900
Copenhagen University Hospital, Gentofte
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Ismail Gögenur, MD Copenhagen University Hospital, Gentofte

ClinicalTrials.gov Identifier: NCT00113906     History of Changes
Other Study ID Numbers: 2004-003796-37
First Posted: June 13, 2005    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: June 2005

Keywords provided by University Hospital, Gentofte, Copenhagen:
melatonin,
fatigue,
sleep quality,
circadian,
postoperative
Postoperative fatigue
postoperative sleep disturbance
general wellbeing

Additional relevant MeSH terms:
Fatigue
Postoperative Complications
Dyssomnias
Signs and Symptoms
Pathologic Processes
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants