To investigate the effect of Melatonin on serum level of interleukin 6 and interleukin 9 in patients undergoing coronary artery bypass grafting(CABG).
Design
Randomized triple blinded clinical trial.
Settings and conduct
42 patients undergoing coronary artery bypass grafting(CABG) in Namazi hospital, Shiraz, Iran randomly divided into two groups of Melatonin or placebo. In the Melatonin group patients receive 10 mg Melatonin every night two weeks before the operation and patients in the placebo group received placebo every night two weeks before the operation. For evaluating serum level of IL-6 and IL-9 in the both groups 4 venous blood samples take from patients (two weeks before administration of melatonin, in the operating room before induction of anesthesia, 6 hours after declamping in the ICU and 48 hours after off pump), samples will have tested with human Th cytokine panel (13-plex), biolegend, USA by “bead-based assay” method & the level of interleukins in different phases: the effect of melatonin on inflammatory factors level will compare in case and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 42 Patients who are candidate for elective CABG with age between 40-75 years old and ASA class <III; pump time less than 90 min; graft number between 2 to 6.
Exclusion criteria: pregnancy and breast feeding; local or systemic infection; hyper sensitivity; redo surgery; surgery during last 6 months; collagen vascular disease; immunosuppressive disease; heart failure with ejection fraction less than 35%; recent cardiovascular event; un controlled HTN; renal failure; liver failure; alcohol abuser; malignancy; simultaneously valvular heart surgery.
Intervention groups
In the Melatonin group patients receive 10 mg Melatonin every night two weeks before the operation and patients in the placebo group received placebo every night two weeks before the operation.
Main outcome variables
serum level of interleukin 6 and interleukin 9
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N72
Registration date:2018-03-06, 1396/12/15
Registration timing:prospective
Last update:2018-03-06, 1396/12/15
Update count:0
Registration date
2018-03-06, 1396/12/15
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
2018-04-04, 1397/01/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on interleukin 6 & interleukin 9 in coronary artery bypass grafting surgery
Public title
The effect of melatonin on interleukin 6 & interleukin 9 in coronary artery bypass grafting surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for elective CABG
age between 40-75 years old
ASA class <III
pump time less than 90 min;
graft number between 2 to 6
Exclusion criteria:
pregnancy
local or systemic infection
hyper sensitivity
redo surgery
surgery during last 6 months
collagen vascular disease
immunosuppressive disease
heart failure with ejection fraction less than 35%
recent cardiovascular event
renal failure
alcohol abuser
simultaneously valvular heart surgery
uncontrolled HTN
liver failure
breast feeding
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
www.randomization.com
Blinding (investigator's opinion)
Triple blinded
Blinding description
patient, accessor and observer are blinded to the study.
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
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SUMS.REC.1396.16
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
serum level of interleukin 6 and interleukin 9
Timepoint
two weeks before administration of melatonin, in the operating room before induction of anesthesia, 6 hours after declamping in the ICU and 48 hours after off pump
Method of measurement
venous blood samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients receive 10 mg Melatonin every night two weeks before the operation.
Category
Prevention
2
Description
Control group: patients in the placebo group received placebo every night two weeks before the operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hoptioal
Full name of responsible person
Mahtab Setoodeh
Street address
Namazi Hoptioal, Namazi Square
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
mahtab.setoodeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
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
mahtab.setoodeh@yahoo.com
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
Mahtab Setoodeh
Position
Anesthesiology resident/physician
Latest degree
Medical doctor
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
Fax
Email
mahtab.setoodeh@yahoo.com
Web page address
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
Fax
Email
joybarr@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Its against our policy.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available