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

Tracking Information

First Received Date ^ICMJE

June 10, 2005

Last Updated Date

January 27, 2010

Start Date ^ICMJE

March 2005

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Fatigue

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00113906 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep quality
general wellbeing
pain

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Melatonin Treatment After Laparoscopic Cholecystectomy

Official Title ^ICMJE

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

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Complications
Fatigue
Dyssomnias

Intervention ^ICMJE

Drug: melatonin

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00113906

Other Study ID Numbers ^ICMJE

2004-003796-37

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Gentofte, Copenhagen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ismail Gögenur, MD

Copenhagen University Hospital, Gentofte

Information Provided By

University Hospital, Gentofte, Copenhagen

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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