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IRCT20231021059795N1 IRCT 2024-04-20 Iran University of Medical Sciences The effect of prescribing intravenous Ketamine in the anesthesia of patients undergoing coronary artery bypass surgery The effect of prescribing intravenous ketamine during induction of anesthesia on the incidence of delirium and the time of endotracheal tube removal in patients undergoing coronary artery bypass surgery 2024-04-09 anticipated 60 Complete https://irct.ir/trial/75125 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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 description: A numerical code will be assigned to each of the rings of the randomly generated chains. Then, the drug regimen is placed in envelopes according to random chains, and after sealing it, a specific number is written on the envelopes, and these envelopes are placed in a box in random order. Blinding: This research will be triple blind. The researcher does not know the type of intervention in the groups. Patients do not know the type of drug group. The anesthesiologist who prescribes the drug and the person who evaluates the patient will be separate, and the patient's information will be recorded based on the ICDSC checklist and the time of extraction by the trained nurses of the special care department who have received sufficient training and explanations before the research and from the group and treatments. Patients are unaware. Also, the statistical analyst will be unaware of the group and treatments of the patients. 3 Condition 1: Delirium. Condition 2: Extubation time. Intervention 1: Intervention group: Intravenous ketamine with a dose of 0.5mg/kg up to a maximum of 50mg will be administered as an infusion in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes during the induction of anesthesia and after the administration of anesthetic drugs. Intervention 2: Control group: the same volume as the intervention group of 0.9% normal saline placebo in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes as an infusion, as a placebo that will be administered during induction of anesthesia and after the administration of anesthetic drugs. Yes - There is a plan to make this available What will be shared: -Only a part of the data, such as the information related to the main result or the like, can be shared. When: Access period 6 months after publication of results To whom: -It will be available only to researchers working in academic and scientific institutions. Conditions: -No special conditions are considered. Where to obtain: Person responsible for the study: Maryam Aligholizadeh gholizade001@gmail.com How to obtain: After receiving the applicant's email, the documents will be sent in a short period of time. Comments:
public Maryam Aligholizadeh
No. 52, Shahid Miri Alley, Rudaki Street, Koi Vahedi
Bandar Anzali Iran (Islamic Republic of) 4317734394 +98 13 4351 2673 gholizade001@gmail.com Iran University of Medical Sciences scientific Maryam Aligholizadeh
No. 52, Shahid Miri Alley, Rudaki Street, Koi Vahedi
Bandar Anzali Iran (Islamic Republic of) 4317734394 +98 13 4351 2673 gholizade001@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Ages between 40 and 80 years ASA class l, ll lll 40 years 80 years Both Having a history of postoperative delirium The presence of underlying mental illness Taking antipsychotic drugs Having a history of alcohol consumption Presence of cerebrovascular disease Perform valvular surgery BMI > 38 kg/m2 Postoperative stroke Postoperative bleeding Longer operation time than usual Need for re-surgery History of underlying lung disease T88.5 T88.5 Other complications of anesthesia Other complications of anesthesia Prevention Placebo Intervention group: Intravenous ketamine with a dose of 0.5mg/kg up to a maximum of 50mg will be administered as an infusion in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes during the induction of anesthesia and after the administration of anesthetic drugs. Control group: the same volume as the intervention group of 0.9% normal saline placebo in 100cc of 0.9% normal saline serum in a maximum time of 5 minutes as an infusion, as a placebo that will be administered during induction of anesthesia and after the administration of anesthetic drugs. Incidence rate of delirium after cardiac surgery. Timepoint: In the first 24 hours and the second 24 hours after the operation. Method of measurement: Intensive Care Delirium Screening Checklist (ICDSC). Extubation time. Timepoint: Up to the first 12 hours of the postoperative period. Method of measurement: Registering patients' extubation time (according to hours: during the first 4 hours after entering the ward, the first 6 hours after entering the ward, the first 8 hours after entering the ward, the first 12 hours after entering the ward). Iran University of Medical Sciences Approved 2023-12-31 Ethics committee of Iran University of Medical Sciences Hemmt Ave, Department of Anesthesia Technology, School of Allied Medical Sciences, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)