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Melatonin Treatment After Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00113906
First Posted: June 13, 2005
Last Update Posted: February 11, 2014
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.
Information provided by:
University Hospital, Gentofte, Copenhagen
  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 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00113906     History of Changes
Other Study ID Numbers: 2004-003796-37
First Submitted: June 10, 2005
First Posted: June 13, 2005
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