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

Evaluating the effect of intravenous erythropoietin administration at the time of anesthesia induction on the incidence of postoperative delirium, hemodynamic stability, and time to tracheal extubation in patients undergoing coronary artery bypass graft (CABG) surgery in the cardiac intensive care unit.

This randomized, triple-blind, placebo-controlled Phase II trial includes 104 CABG patients allocated 1:1 to intervention or control groups. Block randomization (size 4) was generated via Excel RAND function. Sample size (52/group; total 104) was calculated with 95% confidence and 80% power, accounting for dropouts.

This trial at Shahid Beheshti University hospitals involves CABG patients receiving erythropoietin (150 IU/kg) or placebo at induction. Outcomes include delirium (ICDSC), hemodynamics, and extubation time. It is triple-blind (patient, anesthesiologist, assessor, statistician) using identical coded syringes.

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

Intervention Group: Patients in this group will receive a single intravenous (IV) dose of erythropoietin at 150 IU/kg body weight administered at the time of anesthesia induction. Control Group: Patients in this group will receive an equivalent volume of normal saline as a placebo, administered intravenously (IV) at the time of anesthesia induction.

Incidence of postoperative delirium; Hemodynamic stability; Time to tracheal extubation

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 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.

Only a part of the data, such as the information related to the main result or the like, can be shared.

Access period 6 months after publication of results

-It will be available only to researchers working in academic and scientific institutions.

No special conditions are considered.

En Person responsible for the study: Maryam Aligholizadeh gholizade001@gmail.com

After receiving the applicant's email, the documents will be sent in a short period of time.