Effect of melatonin in post operative sleep disorder (POSD) acccording to their Pittsburg sleep quallity index , and cardiac enzymes after coronary artery
bypass graft (CABG)
The goal of this randomized clinical trial is evaluating the effect of melatonin in post operative sleep disorder (POSD) and cardiac enzymes after coronary artery bypass graft (CABG). More than 50% of patients who undergone CABG, will experience sleep disturbance. Melatonin can improve sleep quality beside its antioxidant effects and cardiovascular benefits.
100 patients, who are candidates for CABG, will be randomized to be in control or melatonin group. patients in melatonin group will receive 3 mg melatonin every night, during the time of hospitalization. Their sleep quality will be assessed by the Pittsburgh Sleep Quality Index, at the time of admission, after CABG, and before discharge. The antioxidant and cardiovascular protective effects of melatonin will be assessed by measuring Troponin, CKMB, and CRP at 6, 12, and 24 hours after blood reperfusion during the CABG.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303148698N11
Registration date:2013-04-05, 1392/01/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-05, 1392/01/16
Registrant information
Name
Azita Hajhossein Talasaz
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66954709
Email address
atalasaz@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin in post operative sleep disorder (POSD) acccording to their Pittsburg sleep quallity index , and cardiac enzymes after coronary artery
bypass graft (CABG)
Public title
Effect of melatonin in post operative sleep disorder (POSD), and cardiac biomarckers after coronary artery bypass graft (CABG)
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:
1. Patients who are candidates for CABG procedure.
exclusion criteria:
2. Patients who have been used hypnotic drugs for their sleep disorder.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Kargar shomali street, Tehran Heart Center
City
Tehran
Postal code
Approval date
2013-03-13, 1391/12/23
Ethics committee reference number
755
Health conditions studied
1
Description of health condition studied
patients who are candidate for coronary artery bypass surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Sleep quality
Timepoint
first day of admision, after CABG, At the time of discharge
Method of measurement
PSQI score
2
Description
Cardiac biomarckers (CKMB, Troponin, CRP)
Timepoint
At 6, 12 and 24 hours after blood reperfusion in CABG
Method of measurement
Labratuary kits
Secondary outcomes
1
Description
anxiety
Timepoint
At the time of admision, after CABG, and before discharge
Method of measurement
Hemilton
Intervention groups
1
Description
tab melatonin 3 mg before sleep for 7 nights
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Mehrnoush Dianatkhah
Street address
Kargar shomali street, jalal crossroad, Tehran heart center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sience
Full name of responsible person
Fatemeh saeedi
Street address
16'th azar street, Tehran university of medical sience
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran university of medical sience
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sience
Full name of responsible person
Mehrnoush dianatkhah
Position
resident of pharmacotherapy
Other areas of specialty/work
Street address
16th of azar street, Tehran university of medical sience
City
Tehran
Postal code
Phone
+98 913 201 1241
Fax
Email
mehrnoush_d@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran heart center, Tehran university of medical sience
Full name of responsible person
Azita Haj Hossein Talasaz, padideh ghaeli
Position
assistant, professor
Other areas of specialty/work
Street address
Tehran,kargar shomali street, jalal crossroad, Tehran heart center
City
Tehran
Postal code
Phone
00982188029600, 00982166954709
Fax
Email
atalasaz@razi.tums.ac.ir , mmppg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mehrnoush Dianatkhah
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)