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IRCT20260513069384N1 IRCT 2026-08-06 Bandare-abbas University of Medical Sciences Effect of Melatonin on cardiac biomarkers The prophylactic effect of oral Melatonin on cardiac and inflammatory biomarkers after Artery Bypass Grafting Surgery (CABG) on pump technique 2026-07-23 anticipated 74 Recruiting https://irct.ir/trial/90127 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The study employs a permuted block randomization method. To this end, two treatment groups, A and B, were defined as AB and BA blocks. Random numbers were generated within the range of 0 to 9, where numbers 0–4 were assigned to the AB block, and 5–9 were assigned to the BA block. Upon selecting a random number from the table, if the number falls within 0–4, the AB block is assigned; consequently, the next two participants are enrolled, with the first receiving treatment A and the second receiving treatment B. This procedure is repeated systematically to assign treatment groups for subsequent participants. Although this method ensures an equal number of observations in both groups, the small block size poses a risk of treatment allocation predictability by the investigator. To mitigate this, the randomization list is generated prior to the commencement of the study by an independent, blinded individual who is not involved in the clinical care of the participants, Blinding description: In this double-blind clinical trial, in order to maintain blinding, capsules containing melatonin and placebo before the start of the study were prepared by an independent person outside the research team in identical packages in terms of shape, color, and label and were randomly labeled with codes A and B. The coding key is kept only by this independent person and remains confidential until the completion of statistical analysis and finalization of the results. Allocation of participants to the groups is performed based on these codes. The participants, the principal investigator, and the clinical caregivers (including the treating resident) are unaware of the type of the allocated intervention (melatonin or placebo). Outcome assessment and biomarker measurement are performed by laboratory personnel who are also unaware of the group allocation and the type of intervention. Data analysis is performed by the researcher using coded data (A and B), without access to the coding key. Unblinding of the codes is performed only after completion of the statistical analysis. 3 Coronary artery disease with an indication for coronary artery bypass surgery. Intervention 1: Intervention group: Patients in this group, consisting of 37 individuals, receive one oral melatonin tablet of 3 milligrams manufactured by Razak Company,Iran, 12 hours before surgery, and then on the morning of the day of surgery, they take the second dose, which is another 3 milligram melatonin tablet, orally. Therefore, the total dose received by these patients is 6 milligrams of melatonin administered in two doses. After the patient is transferred to the operating room, standard monitoring, including a non‑invasive blood pressure cuff (NIBP), pulse oximetry, and electrocardiography (ECG), is applied, and baseline hemodynamic parameters, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, are recorded. Then the radial artery of the patient’s non‑dominant hand is anesthetized with 2 percent lidocaine and cannulated with a size 20 pink angiocatheter in order to monitor arterial pressure invasively. Induction of anesthesia is performed with etomidate (0.2 milligrams per kilogram), cisatracurium (0.2 milligrams per kilogram), and fentanyl (10 micrograms per kilogram), and the surgical procedure is started. Maintenance of anesthesia during the operation is carried out using infusion of propofol, atracurium, and sufentanil. The patient receives heparin at a dose of 3 milligrams per kilogram, and after the activated clotting time reaches more than 480, the patient is placed on cardiopulmonary bypass. During the surgery, hemodynamic parameters are recorded every 30 minutes by an anesthesia resident who is unaware of the type of intervention and the patient’s group allocation. In addition, the duration of cardiopulmonary bypass, the duration of aortic cross‑clamping, and the need for inotropic agents are documented in the researcher’s questionnaire. After completion of the surgery, the patient is transferred to the intensive care unit with full monitoring. At this stage, hemodynamic parameters are recorded every 2 hours, and the time to extubation and the duration of the patient’s stay in the intensive care unit are documented by the same anesthesia resident who is unaware of the group allocation. On the second postoperative day, a second blood sample is obtained to measure the inflammatory and cardiac biomarkers again so that they can be compared with the baseline values. Intervention 2: Control group: This group consists of 37 patients. Instead of melatonin, they receive an oral 3-mg sucralose (sugar) tablet manufactured by Dara Kimia Aria, Iran, 12 hours before surgery, with a second oral dose administered on the morning of surgery. The timing of these two doses is identical to that of the intervention group.All subsequent procedures for this group are performed exactly as in the intervention group: application of standard monitoring and recording of baseline parameters upon arrival in the operating room, radial artery cannulation using the same technique, induction of anesthesia with the same agents and doses (etomidate, cisatracurium, and fentanyl), maintenance of anesthesia with the same drug regimen (propofol, atracurium, and sufentanil), and heparinization using the same dose and target activated clotting time (ACT). Intraoperative hemodynamic parameters (recorded every 30 minutes) and ICU hemodynamic parameters (recorded every 2 hours), as well as cardiopulmonary bypass duration, aortic cross-clamp time, inotropic support requirements, extubation time, and ICU length of stay, are recorded by the same anesthesia resident, who is blinded to group allocation, using the same procedures as those applied in the intervention group. Blood samples for biomarker assessment are also collected at the same two time points (baseline and postoperative day 2). 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 There is no further information.
public Farzaneh Akhtari
Shahid Chamran Boulevard, Ghadeer Boulevard
Bandarabas Iran (Islamic Republic of) 7951674852 +98 21 7733 0012 farzaneh@hums.ac.ir Bandare-abbas University of Medical Sciences scientific Farzaneh Akhtari
Shahid Chamran Boulevard, Ghadeer Boulevard
Bandarabas Iran (Islamic Republic of) 7951674852 +98 21 7733 0012 farzaneh@hums.ac.ir Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Patient candidate for Coronery Artery Bypass Grafting(CABG) surgery Patients aged 30 to 80 years Patients with anesthesia class 2 and 3 No receiving analgesic during 6 hours before surgery Patients with ejection fraction greater than 40 percent Patients without a history of renal, hepatic, gastrointestinal disease, or pulmonary failure No addiction to alcohol or narcotic drugs 30 years 80 years Both No willingness to participate in the research project I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris Treatment - Drugs Placebo Intervention group: Patients in this group, consisting of 37 individuals, receive one oral melatonin tablet of 3 milligrams manufactured by Razak Company,Iran, 12 hours before surgery, and then on the morning of the day of surgery, they take the second dose, which is another 3 milligram melatonin tablet, orally. Therefore, the total dose received by these patients is 6 milligrams of melatonin administered in two doses. After the patient is transferred to the operating room, standard monitoring, including a non‑invasive blood pressure cuff (NIBP), pulse oximetry, and electrocardiography (ECG), is applied, and baseline hemodynamic parameters, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, are recorded. Then the radial artery of the patient’s non‑dominant hand is anesthetized with 2 percent lidocaine and cannulated with a size 20 pink angiocatheter in order to monitor arterial pressure invasively. Induction of anesthesia is performed with etomidate (0.2 milligrams per kilogram), cisatracurium (0.2 milligrams per kilogram), and fentanyl (10 micrograms per kilogram), and the surgical procedure is started. Maintenance of anesthesia during the operation is carried out using infusion of propofol, atracurium, and sufentanil. The patient receives heparin at a dose of 3 milligrams per kilogram, and after the activated clotting time reaches more than 480, the patient is placed on cardiopulmonary bypass. During the surgery, hemodynamic parameters are recorded every 30 minutes by an anesthesia resident who is unaware of the type of intervention and the patient’s group allocation. In addition, the duration of cardiopulmonary bypass, the duration of aortic cross‑clamping, and the need for inotropic agents are documented in the researcher’s questionnaire. After completion of the surgery, the patient is transferred to the intensive care unit with full monitoring. At this stage, hemodynamic parameters are recorded every 2 hours, and the time to extubation and the duration of the patient’s stay in the intensive care unit are documented by the same anesthesia resident who is unaware of the group allocation. On the second postoperative day, a second blood sample is obtained to measure the inflammatory and cardiac biomarkers again so that they can be compared with the baseline values. Control group: This group consists of 37 patients. Instead of melatonin, they receive an oral 3-mg sucralose (sugar) tablet manufactured by Dara Kimia Aria, Iran, 12 hours before surgery, with a second oral dose administered on the morning of surgery. The timing of these two doses is identical to that of the intervention group.All subsequent procedures for this group are performed exactly as in the intervention group: application of standard monitoring and recording of baseline parameters upon arrival in the operating room, radial artery cannulation using the same technique, induction of anesthesia with the same agents and doses (etomidate, cisatracurium, and fentanyl), maintenance of anesthesia with the same drug regimen (propofol, atracurium, and sufentanil), and heparinization using the same dose and target activated clotting time (ACT). Intraoperative hemodynamic parameters (recorded every 30 minutes) and ICU hemodynamic parameters (recorded every 2 hours), as well as cardiopulmonary bypass duration, aortic cross-clamp time, inotropic support requirements, extubation time, and ICU length of stay, are recorded by the same anesthesia resident, who is blinded to group allocation, using the same procedures as those applied in the intervention group. Blood samples for biomarker assessment are also collected at the same two time points (baseline and postoperative day 2). Creatine Kinase–Myocardial Band. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: immunoassay. Troponin. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: immunoassay. Erythrocyte Sedimentation Rate. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Westergren method. C-reactive protein serum level. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay methode. Lactate Dehydrogenase serum level. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Spectrophotometer. Interleukine-6 serum level. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay methode. White blood cells count. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Cell counter(hematology analyzer). Platelet count. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Cell counter(hematology analyzer). Hemoglobin level. Timepoint: Before the intervention and two days after completion of the intervention. Method of measurement: Cell counter(hematology analyzer). Mean arterial pressure. Timepoint: Before surgery, every half hour during surgery, and after being transferred to the intensive care unit every two hours. Method of measurement: Arterial catheter. Systolic blood pressure. Timepoint: Before surgery, every half hour during surgery, and after being transferred to the intensive care unit every two hours. Method of measurement: Arterial catheter. Diastolic blood pressure. Timepoint: Before surgery, every half hour during surgery, and after being transferred to the intensive care unit every two hours. Method of measurement: Arterial catheter. Aortic clamp time. Timepoint: During surgery. Method of measurement: Measuring time with a timer and recording it by the anesthesia assistant. Cardiopulmonary pump duration. Timepoint: During surgery. Method of measurement: Measuring time with a timer and recording it by the anesthesia assistant. Need for inotropes. Timepoint: During surgery and after surgery. Method of measurement: Recorded by the anesthesia assistant. Extubation time. Timepoint: After the surgery and moving the patient to the intensive care unit. Method of measurement: Recorded by the anesthesia assistant (by hour). Bandare-abbas University of Medical Sciences Approved 2026-01-27 Ethics committee of Hormozgan University of Medical Sciences Shahid Chamran Boulevard, Ghadeer Boulevard Bandarabbas Hormozgan Iran (Islamic Republic of)