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Completed

NCT Number: NCT00113906

Melatonin Treatment After Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Postoperative Complications Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Glostrup, Glostrup Municipality, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin

Drug

Primary outcomes

  1. Fatigue

Secondary outcomes

  1. Sleep quality

  2. general wellbeing

  3. pain

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 13, 2005
Registry last updated
Feb 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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