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IRCT20141009019470N77 IRCT 2019-03-03 Shiraz University of Medical Sciences The effect of melatonin on cognitive function, after coronary artery bypass grafting surgery. The effect of melatonin on cognitive function, after coronary artery bypass grafting surgery. 2019-03-11 anticipated 50 Complete https://irct.ir/trial/37540 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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. 2-3 Coronary Artery Bypass Grafting Surgery.. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is against our policies.
public Kambiz Zohori
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 kambiz.zohori@yahoo.com Shiraz University of Medical Sciences scientific Reza Jouybar
Anesthesiology Department, Faghihi Hospital, Zand Street
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3647 4270 joybarr@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients aged 40-75 years Patients who are undergoing elective Cardio pulmonary artery bypass grafting. 40 years 75 years Both 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 I25.1 Atherosclerotic heart disease of native coronary artery Prevention Placebo 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.. 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. Cognitive function. Timepoint: 4 weeks before surgery,2 days after surgery and 6 weeks after melatonin administration. Method of measurement: Cognitive function Test. Shiraz University of Medical Sciences Approved 2017-08-26 Ethics committee of Shiraz University of Medical Sciences Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)