Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113906
Status:
COMPLETED
Last Update Posted:
2014-02-11
First Post:
2005-06-10
Brief Title:
Melatonin Treatment After Laparoscopic Cholecystectomy
Sponsor:
University Hospital Gentofte Copenhagen
Organization:
University Hospital Gentofte Copenhagen
Study Overview
Official Title:
The Effect of Melatonin Treatment on Postoperative Fatigue and Sleep Disturbances A Placebo Controlled Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None