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IRCT20230820059193N1 IRCT 2023-08-30 Karaj University of Medical Sciences Investigating the effect of Melatonin supplement on the incidence of Delirium After Coronary Artery Bypass Graft surgery Investigating the Effect of Melatonin Supplement on the Incidence of Delirium in Patients Undergoing Coronary Artery Bypass Graft Surgery in a Three-blind, Placebo-controlled Clinical Trial. 2023-09-23 anticipated 146 Complete https://irct.ir/trial/72184 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Balanced randomization by using random blocks. Unit of randomization: Individual patients Randomization tool: Sealed envelope containing intervention group By using random block tables, 37 blocks of 4 members according to a total of approximately 146 sample size will be chosen. Within each block there will be 2 interventions and 2 placebos. Permutations will be random and allocation to the study groups will be applied by using sealed envelope. Patients and medical providers will be unaware of the randomization scheme and study groups, Blinding description: Healthcare Personnel (Including Doctors, Nurses), Students (Principal Researcher), Participants, and the Person Evaluating the Results and the Analyst Do not Know About Receiving the Drug or Placebo. A Concealment envelope will assign patients to intervention group according to random block table. Melatonin and placebo capsule will be identical for keeping patients and medical providers blinded. 3 Incidence of Delirium After Coronary Artery Bypass Surgery. Intervention 1: Intervention group (Drug Group): 1 Oral tablet of Melatonin 10 mg manufactured by Jalinous Iran company will be taken at night from 3 days before surgery and up to 5 days after surgery. Intervention 2: Control group: 1 Oral Tablet, Ineffective But Similar to the Medicine (Placebo) Manufactured by Jalinous Iran Company will be Taken at Night from 3 Days Before Surgery and up to 5 Days After Surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is It will be explained after the judging.
public Maryam Daei
Faculty of Pharmacy building, Valiasr St., Shura Blvd., next to Bahnar Hospital
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 marydaei@yahoo.com Karaj University of Medical Sciences scientific Maryam Daei
Faculty of Pharmacy building, Valiasr St., Shura Blvd., next to Bahnar Hospital
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 marydaei@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age, whose blood supply disorder to the heart makes them candidates for Coronary Artery Bypass Graft surgery Patients who have no problem understanding Persian language Signing the consent form by the patient (Consent is obtained from patients in written and verbal form) 18 years no limit Both People who have a history of allergic reaction to Melatonin or other ingredients in the pill Patients who suffered cardiac and respiratory arrest Patients who Have a history of mental disorders such as Psychosis and Mental Retardation Patients who take Antipsychotic drugs Patients with a history of Seizures Patients with a history of Delirium Patients with Alzheimer's Patients with severe Kidney and Liver failure Patients with Alcohol or drug addiction Patients who need reoperation due to abnormal bleeding Patients who are deaf Patients who do not have the ability to speak to answer the questions in the questionnaire Patients who are unable to swallow oral Melatonin Patients who are candidates for emergency surgery Pregnant and Lactating women If older people had medicines that interfered with my research Older people who are not able to participate in this plan for any reason F05.8 Postoperative delirium Prevention Placebo Intervention group (Drug Group): 1 Oral tablet of Melatonin 10 mg manufactured by Jalinous Iran company will be taken at night from 3 days before surgery and up to 5 days after surgery. Control group: 1 Oral Tablet, Ineffective But Similar to the Medicine (Placebo) Manufactured by Jalinous Iran Company will be Taken at Night from 3 Days Before Surgery and up to 5 Days After Surgery. The rate of Delirium after surgery during the first 5 days after surgery. Timepoint: Investigation and recognition of confusion and monitoring of Delirium in patients of special care department is done on the day of operation and up to two days after the operation. Method of measurement: The confusion assessment-special care (CAM-ICU) questionnaire is used to investigate and recognize confusion and monitor delusions. Measuring the intensity of delirium. Timepoint: After the diagnosis of delirium until two days after the operation, its severity is checked further. Method of measurement: Confusion Assessment Method-severity (CAM-S) questionnaire. Measuring the level of alertness and the patient's responses to stimuli (Eye response - verbal response - motor response). Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Glasgow Coma Scale (GCS) Scoring system. Check the quality of sleep. Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Epworth Sleep scale questionnaire (ESS). Examining the pain intensity of patients. Timepoint: Daily from 3 days before surgery to 5 days after. Method of measurement: Numeric Rating Scale questionnaire (NRS). Duration of hospitalization in the intensive care unit. Timepoint: daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file. Duration of hospitalization. Timepoint: daily from the day after surgery. Method of measurement: Counting the number of days a person is hospitalized in the intensive care unit of the hospital after surgery and based on the patient's admission file. Measuring the duration of delirium. Timepoint: From the time people are diagnosed with delirium until the time they recover. Method of measurement: Count the number of days. Karaj University of Medical Sciences Approved 2023-08-12 Ethics Committee of Alborz University of Medical Sciences 2th floor, Research and Technology Deputy Bldg, Research Ethics Office, 45 meter Golshahr, Shahid Safarian Alley Karaj Alborz Iran (Islamic Republic of)