Investigating the effect of Quetiapine on delirium in patients undergoing coronary artery bypass graft surgery; a double-blind clinical trial

Investigating the effect of quetiapine on delirium in patients undergoing CABG surgery

A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial of 82 patients. For randomization, a random sequence created in blocks of four using the site http://www.graphpad. com/quickcalcs/index.cfm will be used.

This study will be conducted as a clinical trial in Heshmat Hospital in Rasht. After explaining the purpose and method of the research, informed consent will be obtained. Patients will be randomly divided into intervention and control groups. The medicine will be given to the patient by a nurse who is not in the study. The drug will be administered orally or through a nasogastric/intestinal tube. Delirium examination of patients in the ICU will be evaluated by a trained anesthesiologist on a daily basis, from the day of surgery until the patient's discharge from the ICU. The delirium assessment criteria will be the CAM-ICU scale (Confusion Assessment Method for the ICU). This study will be double-blinded. The patient and the evaluator (anesthetist assistant) will be unaware of the treatment groups. The anesthesiologist of the ICU team is aware of the groups so that in case of complications, therapeutic interventions can be performed.

Inclusion criteria: Elective patients , 35-85 years, ASA Class II,III, GCS 15. Exclusion criteria: liver and kidney failure, history of mental illness and cognitive behavioral problems.

Intervention group:12.5 mg of oral quetiapine , the first dose on the morning of surgery, before surgery (quetiapine 25 mg tablet), and then every 12 hours until 48 hours after surgery, for a total of 4 doses. Control group: will not receive any drug prophylaxis.

Occurrence of delirium during ICU hospitalization

1- Editing information related to Inclusion criteria(GCS 15, ASA Class II,III): GCS 15 is appropriate because the assessment of postoperative delirium in patients entering the study must be clinically fully conscious. ASA Class II,III is appropriate because ASA Class IV is for patients undergoing emergency surgery, but this study was conducted in patients who were candidates for elective coronary artery bypass grafting. 2- In the intervention section, the method of administering quetiapine was described in more detail and revised. Also, the time period for examining delirium in postoperative patients was revised to 3 days after surgery, as patients are hospitalized in the ICU for a maximum of three days after surgery.

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.

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.