]>
IRCT20080830001127N9 IRCT 2022-12-04 Tabriz University of Medical Sciences Comparison of the effect of haloperidol versus dexmedetomidine in the prevention of delirium after cardiac surgery Comparison of the effect of haloperidol versus dexmedetomidine in the prevention of delirium after cardiac surgery 2023-01-21 anticipated 180 Complete https://irct.ir/trial/67067 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be done by random distribution in blocks of 9 based by on line software (www.randomlists.com), Blinding description: Anesthesiologists who are responsible for managing the patient during and after the operation, diagnosing delirium and collecting data will administer the drug under investigation through coded syringes, the drug will be prepared by a nurse colleague. All these specialists will be unaware of the type of drug injected to the patient. The nurse's colleague will not have any role in the process of patient management, data collection and variables examined in the patient. The patient will also be unaware of the type of injected medicine. 3 Delirium. Intervention 1: Intervention group: As soon as the patient is admitted to the ICU, the loading dose and then the infusion of dexmedetomidine will be started. Intervention 2: Intervention group: As soon as the patient is admitted to the ICU, the loading dose and then the infusion of haloperidol will be started. 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 Protection of patients' personal information
public Eissa Bilehjani
Madani Heart Center, Daneshgah Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3337 3950 isasdavod@gmail.com Tabriz University of Medical Sciences scientific Eissa Bilehjani
Madani Heart Center, Daneshgah Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166615573 +98 41 3337 3950 isadavod@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) All adult patients 18 up to 75 years old , candidates of elective cardiac surgery with cardiopulmonary bypass 18 years 75 years Both History of previous CVA without full recovery for 5 years - emergency procedures - death in ICU Emergency surgeries Death in ICU Patients under 18 years old and over 75 years old History of neurological and mental diseases or taking antipsychotic drugs Not using cardiopulmonary bypass Allergy to haloperidol or dexmedetomidine Dementia QTc interval greater than 500 ms or complete heart block History of malignant neuroleptic syndrome Bradycardia Liver and kidney diseases f05 Other delirium Prevention Prevention Intervention group: As soon as the patient is admitted to the ICU, the loading dose and then the infusion of dexmedetomidine will be started. Intervention group: As soon as the patient is admitted to the ICU, the loading dose and then the infusion of haloperidol will be started. Delirium. Timepoint: during ICU stay. Method of measurement: CAM–ICU measurement tool. Duration of need to mechanical ventilation. Timepoint: During hospitalization in ICU. Method of measurement: Counting the number of hours of mechanical ventilation in the ICU. Length of stay in ICU. Timepoint: Reviewing the patient ICU records. Method of measurement: Counting the number of days of ICU stay. Mortality. Timepoint: During hospitalization in ICU. Method of measurement: Reviewing the patient ICU records. Tabriz University of Medical Sciences Approved 2022-06-01 Ethics committee of tabriz University of Medical Sciences Vice chancellor for research, Golgasht street tabriz East Azarbaijan Iran (Islamic Republic of)