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General information
2019-04-09, 1398/01/20
2019-07-25, 1398/05/03
2019-0407-0925 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Namazi Hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Kambiz Zohori
Full name of responsible person - Persian: کامبیز ظهوری
Street address - English: Namazi Hospital, Namazi Square
Street address - Persian: فلکه نمازی، بیمارستان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: masihifarzaneh@yahoo.com
Web page address:
Name of recruitment center - English: Namazi Hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Kambiz Zohori
Full name of responsible person - Persian: کامبیز ظهوری
Street address - English: Namazi Hospital, Namazi Square
Street address - Persian: فلکه نمازی، بیمارستان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: namazi@sums.ac.ir
Web page address:
Name of recruitment center - English: Namazi Hospital Name of recruitment center - Persian: بیمارستان نمازی Full name of responsible person - English: Kambiz Zohori Full name of responsible person - Persian: کامبیز ظهوری Street address - English: Namazi Hospital, Namazi Square Street address - Persian: فلکه نمازی، بیمارستان نمازی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134844119 Phone: +98 71 3647 4270 Fax: Email: masihifarzanehnamazi@yahoo.comsums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Younes Ghasemi
Full name of responsible person - Persian: دکتر یونس قاسمی
Street address - English: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: masihifarzaneh@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Younes Ghasemi
Full name of responsible person - Persian: دکتر یونس قاسمی
Street address - English: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: sacrc@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Younes Ghasemi Full name of responsible person - Persian: دکتر یونس قاسمی Street address - English: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134844119 Phone: +98 71 3647 4270 Fax: Email: masihifarzanehsacrc@yahoo.comsums.ac.ir Web page address:
Protocol summary
Study aim
To evaluate the effect of melatonin on cognitive function, after coronary artery bypass grafting surgery.
Design
Double blind randomized clinical trial
Settings and conduct
50 patients undergoing coronary artery bypass grafting are divided into two groups. Patients in the first group received 10 mg melatonin 4 weeks before surgery, 2 days after surgery and patients in the second group received placebo.The patients will be evaluated by cognitive function tests 4 weeks before surgery, 2 days after surgery and 6 weeks after melatonin administration.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 40-75 years; Patients who are undergoing elective Cardio pulmonary artery bypass grafting.
Exclusion criteria: Acute recent Myocardial Infarction (less than 3 month); Emergency operation; Re-operation; Concomitant renal insufficiency; Immunologic disorders; Concomitant cerebrovascular disease; prior stroke; severe pulmonary disease ; Ejection Fraction< 45%; ASA> 3; Current anticoagulation therapy with warfarin; concomitant cardiac surgery; Non sinus ECG; Hepatic insufficiency; Alcohol abuse; Regular medication with Benzodiazepines and opioid; Psychiatric disorders; Dementia; Pregnancy; breast feeding; Any infection less than 4 weeks ago; corticosteroid therapy since 1 month ago; Pump time more than 90 min; Peripheral vascular disease; Renal dysfunction; aortic atheromatosis .
Intervention groups
Intervention group: Patients received two oral capsules of melatonin 5 mg daily (Super Natural ,Canada)four weeks prior to surgery and up to two days after surgery.
control group: patients received two oral placebo capsules daily made by Shiraz School of pharmacy at the same time periods.
Main outcome variables
Cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N77
Registration date:2019-03-03, 1397/12/12
Registration timing:prospective
Last update:2019-08-13, 1398/05/22
Update count:1
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-11, 1397/12/20
Expected recruitment end date
2019-07-25, 1398/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on cognitive function, after coronary artery bypass grafting surgery.
Public title
The effect of melatonin on cognitive function, after coronary artery bypass grafting surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 40-75 years
Patients who are undergoing elective Cardio pulmonary artery bypass grafting.
Exclusion criteria:
Acute recent Myocardial Infarction (less than 3 month)
Aortic atheromatosis
Renal dysfunction;
Peripheral vascular disease;
Pump time more than 90 min;
Corticosteroid therapy since 1 month ago;
infection less than 4 weeks ago;
Breast feeding
Pregnancy;
Dementia;
Psychiatric disorders
Using Benzodiazepines and opioid;
Alcohol abuse
Hepatic insufficiency
Non sinus ECG;
Concomitant cardiac surgery;
Anticoagulation therapy with warfarin
ASA higher than 3
Ejection Fraction less than 45%
Severe pulmonary disease
Cerebrovascular disease
Immunologic disorders
Re-operation
Emergency operation
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The medicine or placebo are provided by a nurse who is aware of the study groups to the nurse who is unaware of the study groups and responsible for prescribing the medicine.
Due to the complete similarity of the drug and placebo, the responsible nurse, the patient and the assessor are also not aware of the type of drug or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2017-08-26, 1396/06/04
Ethics committee reference number
IR.SUMS.MED.REC.1396.40
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Grafting Surgery.
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Cognitive function
Timepoint
4 weeks before surgery,2 days after surgery and 6 weeks after melatonin administration.
Method of measurement
Cognitive function Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients received two oral capsules of melatonin 5 mg daily made by (Super Natural ,Canada)from four weeks prior to surgery and up to two days after surgery..
Category
Prevention
2
Description
Control group:Patients received two oral placebo capsules daily made by Shiraz School of pharmacy from four weeks prior to surgery and up to two days after surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Kambiz Zohori
Street address
Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
namazi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Kambiz Zohori
Position
Physician/cardiac anesthesia fellowship
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
kambiz.zohori@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
joybarr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Others
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available