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IRCT20250512065695N1 IRCT 2025-05-16 Mashhad University of Medical Sciences Dexmedetomidine infusion effect on post-operative delirium The effect of Dexmedetomidine infusion on post-operative delirium (POD) in patients on pump coronary artery bypass grafting (CABG) 2025-05-22 anticipated 100 Complete https://irct.ir/trial/83495 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be allocated to the two study arms using a block randomization method. A total of 10 random blocks with variable sizes of 4 and 6 and differing sequences have been prepared. The contents of each block are sealed in opaque envelopes. As patients are enrolled, the envelopes are opened sequentially, and based on the sequence within the block, the patient is assigned to one of the study arms. Subsequently, after completing the first block, the next block is randomly selected, and this process continues until the final block is used and the last patient is assigned. As a result, with the allocation of the last entry in the final block, an equal number of patients will be assigned to each study arm, ensuring balance between the groups, Blinding description: Participant: The participant consented to be randomly allocated to either the intervention group or the control group after understanding the study procedures. Researcher: The researcher was not allowed bedside access prior to randomization to prevent any potential bias. Assessor: The assessor was unaware of the treatment received by the participant and solely recorded the outcomes. 3 on-pump coronary artery bypass graft surgery. Intervention 1: Intervention group: Intravenous infusion of dexmedetomidine after the induction of anesthesia, starting at a dose of 0.6 micrograms per kilogram per hour, and continued until the end of the procedure based on the patient's hemodynamics. Intervention 2: Control group: Normal saline infusion is initiated intravenously after the induction of anesthesia, starting with the same volume as dexmedetomidine, and continues throughout the procedure, adjusted according to the patient's hemodynamics, and is terminated at the end of the operation. 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 Shiva Rezaeian
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Educational Research and Treatment Center
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3604 6080 shivarezaeian7388@gmail.com Mashhad University of Medical Sciences scientific Leila Mashhadi
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Educational Research and Treatment Center
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3604 6080 mashhadil@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients scheduled for on-pump coronary artery bypass grafting (CABG) Informed consent Patients with sufficient cognitive function to participate in the study (assessed by MMSE) Psychological status: Patients with acceptable levels of depression and anxiety (assessed by PHQ-4) Absence of preoperative delirium: Patients without signs of delirium before surgery No severe hepatic or renal failure 18 years 80 years Both Concurrent valve replacement surgery along with CABG Emergency CABG surgery Known allergy or hypersensitivity to dexmedetomidine Patients in a coma or intubated prior to surgery Patients with moderate to severe hearing impairment or deafness Bradycardia (heart rate <60 bpm) at the time of anesthesia induction Hypotension (systolic blood pressure <100 mmHg) at the time of anesthesia induction Need for reoperation within the first postoperative day Withdrawal of patient consent at any stage during hospitalization Z95.1 Presence of aortocoronary bypass graft Prevention Placebo Intervention group: Intravenous infusion of dexmedetomidine after the induction of anesthesia, starting at a dose of 0.6 micrograms per kilogram per hour, and continued until the end of the procedure based on the patient's hemodynamics. Control group: Normal saline infusion is initiated intravenously after the induction of anesthesia, starting with the same volume as dexmedetomidine, and continues throughout the procedure, adjusted according to the patient's hemodynamics, and is terminated at the end of the operation Determining the incidence of confusion and delirium in intervention and control groups. Timepoint: In the first and second days after surgery in the cardiac ICU, daily assessments will be conducted during each shift. Method of measurement: Neelon & Champagne Confusion Scale. Determining the incidence of delirium in intervention and control groups. Timepoint: In the first and second days after surgery in the cardiac ICU, daily assessments will be conducted during each shift. Method of measurement: CAM-ICU Scale. Mashhad University of Medical Sciences Approved 2024-06-10 Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad Ibn Sina St., Imam Reza Hospital Square, Imam Reza Educational Research and Treatment Center Mashhad Razavi Khorasan Iran (Islamic Republic of)