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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable