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IRCT20080830001127N8 IRCT 2020-04-18 Tabriz University of Medical Sciences Haloperidol effect on postoperative delirium prophylaxis Comparison of haloperidol and placebo in the prevention of delirium after heart surgery 2020-02-20 anticipated 180 Complete https://irct.ir/trial/46848 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients wishing to participate in the study who meet the inclusion criteria will be selected through convenient sampling and then randomly assigned to two control and intervention groups using Randlist software and blocks of size two, Blinding description: The anesthesiologist who is responsible for the patients management of anesthesia will administer the medicine(s) via coded syringes had been prepared previously and will not be aware of the injected drug, and anesthesia nurse who is responsible for collection of patients information and study variables and is unaware of the administered drug will record the check- list during surgery and in the recovery.Also the patient is unaware of the injected medicine. 3 Delirium. Intervention 1: Intervention group: In this group, haloperidol (HALODIC, ampoule of 5 mg per 1 ml, produced by Caspian company) with a concentration of 0.5 mg / cc will be injected immediately after the onset of pulmonary heart bypass (CPB). Intervention 2: Control group: In this group, only distilled water (as a placebo) will be prescribed with the same characteristics of the drugs used in the intervention group. Yes - There is a plan to make this available What will be shared: A portion of the data that represents the final outcome When: starting 6 months after publication To whom: All Physicians and residents of the department of Anesthesia Conditions: There will be no specific limitations to the utilization of the data. Where to obtain: Dr .Eissa Bilehjani,Madani Heart Center, Daneshgah Street, Tabriz, Tn Phone+98 41 33373950 Fax+98 41 33373950 bilehjanii@tbzmed.ac.ir How to obtain: Be approved by the Research Vice-President at first Comments:
public Eissa Bilehjani
Madani Heart Center, Daneshgah street, Tabriz
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3337 3950 bilehjanii@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Eissa Bilehjani
Madani Heart Center, Daneshgah street, Tabriz
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3337 3950 bilehjanii@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) All adult patients between the ages of 18 and 75 years old and candidates for elective cardiac surgery 18 years 75 years Both History of neurological diseases Allergy to haloperidol Parkinson's disease A history of stroke Emergency surgery Previous use of anti-psychotic drugs F05.8 Other delirium Treatment - Drugs Treatment - Drugs Intervention group: In this group, haloperidol (HALODIC, ampoule of 5 mg per 1 ml, produced by Caspian company) with a concentration of 0.5 mg / cc will be injected immediately after the onset of pulmonary heart bypass (CPB). Control group: In this group, only distilled water (as a placebo) will be prescribed with the same characteristics of the drugs used in the intervention group. Delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using the Richmond Agitation-Sedation Scale criterion. Intensity of delirium. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using CAM-ICU confusion recognition and review tools. Blood pressure. Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day. Method of measurement: Using a mercury barometer. Laboratory variables (sodium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values. Laboratory variables(potassium ). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values. ŮŽArterial blood gas (ABG). Timepoint: Before entering the ICU, before the pump, during the pump, after the pump, the first day of the ICU, the second day of the ICU, the third day of the ICU. Method of measurement: By taking blood and determining laboratory values. Tabriz University of Medical Sciences Approved 2020-02-01 Ethics Committee of Tabriz University of Medical Sciences Vice chancellor for research, Golgasht street Tabriz East Azarbaijan Iran (Islamic Republic of)