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IRCT20231021059795N2 IRCT 2026-06-10 Shahid Beheshti University of Medical Sciences The effect of intravenous erythropoietin administration at the time of anesthesia induction on the incidence of delirium, hemodynamic stability, and time to tracheal extubation in patients undergoing coronary artery bypass graft (CABG) surgery The Effect of Intravenous Erythropoietin Administration at the Time of Anesthesia Induction on the Incidence of Delirium, Hemodynamic Stability, and Time to Tracheal Extubation in Patients Undergoing Coronary Artery Bypass Graft Surgery 2026-06-22 anticipated 104 Complete https://irct.ir/trial/90699 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the block randomization method will be used using blocks of six in random order. Then the patients who will meet the entry criteria; According to the block randomization method, they will be placed in groups (in this method, the treatment blocks are moved back and forth randomly and different situations can be created with blocks of length 6 for two groups, for example: ABCABC-BACABC-ABCBAC-ABCCBA... and The mentioned situations continue until the sample volume is filled). Blocks will be randomly selected with Excel software and at the disposal of a researcher who has no involvement in choosing the type of intervention; Placed, Blinding description: Blinding Method: This study will be conducted as a triple-blind trial. To achieve this, after generating the random sequence using Excel software, the intervention drug (Erythropoietin) and the placebo (Normal Saline) will be prepared in identical, unlabeled syringes. A unique numeric code will be assigned to each syringe, and the key linking codes to the specific treatments will be kept in sealed, opaque envelopes, accessible only in emergency situations. In this study: Patients are blinded to the type of treatment received (Erythropoietin or Placebo). The Anesthesiologist administering the drug is unaware of the syringe contents and administers the injection solely based on the assigned code. Outcome Assessors, including trained ICU nurses responsible for recording delirium scores (ICDSC), hemodynamic parameters, and tracheal extubation time, are blinded to the patients' group assignments. The Statistical Analyst will remain blinded to the group allocations until the completion of data analysis. All personnel involved in data collection will receive adequate training prior to the study commencement to ensure the integrity of the blinding process. 3 Condition 1: delirium. Condition 2: Extubation time. Condition 3: Hemodynamic stability. Intervention 1: Patients will receive a single intravenous dose of erythropoietin (150 IU/kg) at the time of anesthesia induction. Intervention 2: Patients will receive an equivalent volume of normal saline as a placebo, administered intravenously at the time of anesthesia induction. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: Access period 6 months after publication of results To whom: -It will be available only to researchers working in academic and scientific institutions. Conditions: No special conditions are considered. Where to obtain: En Person responsible for the study: Maryam Aligholizadeh gholizade001@gmail.com How to obtain: After receiving the applicant's email, the documents will be sent in a short period of time. Comments:
public Siavash Sangi
Niayesh Intersection - Shahid Beheshti School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 88655366 siavashsangi@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam Aligholizadeh
Niayesh Intersection - Shahid Beheshti School of Nursing and Midwifery
Tehran Iran (Islamic Republic of) 1996835119 88655366 gholizade001@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 40 to 80 yearsASA physical status classification I, II, or IIINo history of postoperative deliriumNo underlying psychiatric disorders or use of antipsychotic medicationsNo history of alcohol consumption or cerebrovascular disease 40 years 80 years Both Occurrence of postoperative stroke or hemorrhage. Receipt of high-dose opioids in the ICU: more than 2400 mcg of fentanyl equivalent within 24 hours (equivalent to a mean of 100 mcg/hour) or 240 mg of morphine equivalent within 24 hours (equivalent to 10 mg/hour). Prolonged surgery duration exceeding 3 hours.Concurrent valve surgery. BMI > 38 kg/m². Need for re-operation T88.5 T88.5 T88.5 Other complications of anesthesia Other complications of anesthesia Other complications of anesthesia Treatment - Drugs Placebo Patients will receive a single intravenous dose of erythropoietin (150 IU/kg) at the time of anesthesia induction. Patients will receive an equivalent volume of normal saline as a placebo, administered intravenously at the time of anesthesia induction. Incidence rate of delirium after cardiac surgery. Timepoint: Every 6 hours after surgery for up to 72 hours. Method of measurement: Intensive Care Delirium Screening Checklist (ICDSC). Extubation time. Timepoint: Up to the first 12 hours of the postoperative period. Method of measurement: Registering patients' extubation time (according to hours: during the first 4 hours after entering the ward, the first 6 hours after entering the ward, the first 8 hours after entering the ward, the first 12 hours after entering the ward). Hemodynamic stability. Timepoint: Every 6 hours after surgery for up to 72 hours. Method of measurement: Invasive monitoring devices (IBP, CVP, EKG, pulse oximetry) and arterial blood gas (ABG) analysis are used to record hemodynamic and respiratory parameters. Shahid Beheshti University of Medical Sciences Approved 2025-11-23 Shahid Beheshti University of Medical Sciences تهران- بزرگراه شهید چمران - خیابان یمن - خیابان اعرابي، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید بهشتی- ساختمان شماره دو ستاد دانشگاه- طبقه ششم Tehran Tehran Iran (Islamic Republic of)