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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: January 27, 2010
Last verified: June 2005
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

Drug Information available for: Melatonin
U.S. FDA Resources

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 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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00113906     History of Changes
Other Study ID Numbers: 2004-003796-37
Study First Received: June 10, 2005
Last Updated: January 27, 2010
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

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

ClinicalTrials.gov processed this record on June 13, 2013