Back to resultsMelatonin Treatment After Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Complications, Fatigue, Dyssomnias
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
melatonin
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications focused on measuring melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
Eligibility 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
Sites / Locations
- University Hospital of Glostrup
- Copenhagen University Hospital, Gentofte
Outcomes
Primary Outcome Measures
Fatigue
Secondary Outcome Measures
Sleep quality
general wellbeing
pain
Full Information
NCT ID
NCT00113906
First Posted
June 10, 2005
Last Updated
February 10, 2014
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT00113906
Brief Title
Melatonin Treatment After Laparoscopic Cholecystectomy
Official Title
The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances: A Placebo Controlled Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Fatigue, Dyssomnias
Keywords
melatonin,, fatigue,, sleep quality,, circadian,, postoperative, Postoperative fatigue, postoperative sleep disturbance, general wellbeing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
melatonin
Primary Outcome Measure Information:
Title
Fatigue
Secondary Outcome Measure Information:
Title
Sleep quality
Title
general wellbeing
Title
pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Gögenur, MD
Organizational Affiliation
Copenhagen University Hospital, Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Glostrup
City
Glostrup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Copenhagen University Hospital, Gentofte
City
Hellerup
State/Province
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
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Melatonin Treatment After Laparoscopic Cholecystectomy
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