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IRCT20130525013456N7 IRCT 2023-08-21 Rasht University of Medical Sciences effect of Quetiapine on delirium in patients undergoing coronary artery bypass graft surgery Investigating the effect of Quetiapine on delirium in patients undergoing coronary artery bypass graft surgery; a double-blind clinical trial 2023-08-23 anticipated 82 Complete https://irct.ir/trial/71863 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be assigned to two groups: quetiapine and control by a random sequence created in blocks of four by using the site http://www.graphpad.com/quickcalcs/index.cfm, which was created by a statistical consultant in a ratio of 1:1 and will be performed by a nurse who is not aware of the goals of the study, Blinding description: In this double-blind study, the drug will be given to the patient by a nurse who is not participating in the study, and the delirium of patients in the ICU will be evaluated and recorded by a trained anesthesia assistant who is unaware of the treatment groups. In this way, the patient and the person evaluating and recording the information (trained anesthesia assistant) will be unaware of the treatment groups. The anesthesiologist of the ICU team will be aware of the groups to take the necessary actions in case of complications. 3 Determining the effect of Quetiapine on delirium in patients undergoing CABG surgery. Intervention 1: Intervention group: The group will receive 12.5 mg of oral quetiapine, the first dose on the morning of surgery, then every 12 hours until 48 hours after surgery (25 mg quetiapine tablets manufactured by Fatek Shimi Pars Company - Iran), for a total of 4 doses, by a nurse who is not in the study. In patients with a nasogastric/intestinal tube, the patient's dose of quetiapine will be crushed, mixed with 10 ml of water and administered through the nasogastric/intestinal tube. The feeding tubes will be flushed with 30 ml of sterile water after each dose of quetiapine according to hospital protocol. Intervention 2: Control group: The control group will not have any medical prophylaxis. 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 Not decided yet
public Abbas Sedighinejad
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 A_sedighinejad@yahoo.com Rasht University of Medical Sciences scientific Abbas Sedighinejad
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 A_sedighinejad@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Elective patients who are candidates for coronary artery bypass surgery 85- 35 years American Society of Anesthesiologists (ASA) II,III GCS 15 to be fully alert and able to communicate 35 years 85 years Both Liver and kidney failure Emergency surgery Confirmation of delirium before ICU admission Patients with a history of mental illness and cognitive behavioral problems before surgery Allergy to quetiapine and its ingredients F05.8 Postoperative delirium Prevention Prevention Intervention group: The group will receive 12.5 mg of oral quetiapine, the first dose on the morning of surgery, then every 12 hours until 48 hours after surgery (25 mg quetiapine tablets manufactured by Fatek Shimi Pars Company - Iran), for a total of 4 doses, by a nurse who is not in the study. In patients with a nasogastric/intestinal tube, the patient's dose of quetiapine will be crushed, mixed with 10 ml of water and administered through the nasogastric/intestinal tube. The feeding tubes will be flushed with 30 ml of sterile water after each dose of quetiapine according to hospital protocol. Control group: The control group will not have any medical prophylaxis. Occurrence of delirium during ICU hospitalization. Timepoint: Daily from the day of surgery until the patient is discharged from the ICU (for 3 days). Method of measurement: CAM- ICU (Confusion Assessment Method for the ICU). Side effects of the drug. Timepoint: Daily. Method of measurement: Observation. Rasht University of Medical Sciences Approved 2023-07-26 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)