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IRCT20221128056654N1 IRCT 2023-04-16 Esfahan University of Medical Sciences Investigation of Dexmedetomidine and Haloperidol in Delirium symptoms in Intensive Care Unit patients. Comparison of the efficacy and adverse effects of dexmedetomidine and haloperidol in reducing the symptoms of Deliriumin patients in Intensive Care Unit - A Randomized Clinical Trial. 2022-12-22 anticipated 74 Complete https://irct.ir/trial/67251 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The investigated samples will be divided into two groups using a simple randomization method. The selection of this randomization method is based on the sample size of the present study (less than 100 people) to ensure an equal number of people in each group. Individual randomization unit and random number table randomization tool. In order to hide the random allocation, sealed opaque envelopes with a random sequence are used in such a way that first the random sequence is created using the mentioned method, then based on the sample size of the research,A number of envelopes are prepared with aluminum envelopes (so that the contents of the envelopes are not clear) and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to preserve the random sequence, on The outer surface of the envelopes is numbered in the same order.Finally, the lid of the envelopes is glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes is opened in order and the assigned group is assigned to it. The participant will be revealed. The process of random allocation is carried out in such a way that one person will create the random sequence and the other person will check the participants in terms of entry and exit criteria and enroll them in the study and the person Third, it will assign the participants to groups, Blinding description: This study is a double-blind study in such a way that the patient and the assistant who collects the information and fills the questionnaires are kept blind. Both drugs are used in the form of vials and intravenous injections in patients hospitalized in the intensive care unit, so the participant is not aware of the type of injected drug. 1-2 delirium. Intervention 1: In the group receiving dexmedetomidine manufactured by Exir pharmaceutical company, the drug is administered intravenously with a starting dose of 0.5 μg/kg per hour. To achieve the effect of the drug, at least one hour of injection is required. Therefore, after one hour, the patient is evaluated through the RASS questionnaire, and if a score of zero is obtained, the drug is continued with the same dose for 72 hours, and the RASS questionnaire is administered every hour for 6 hours and then every 12 hours until the end of 72 hours from the start of the intervention. will be completed If after the injection with the initial dose, a score higher than zero is obtained in the RASS questionnaire, the injection is continued with a dose of 0.8 μg/kg per hour, and the assessment of the patient's condition is carried out in the same order as mentioned above.If the patient's agitation is not controlled with this dose (a score of zero in the RASS questionnaire means a suitable response to the treatment), in the next step, the drug is injected at a dose of 1.2 μg/kg per hour. If the agitation is not controlled with this dose, The result is considered as the ineffectiveness of the drug in controlling the patient's symptoms, and other drugs are used according to the patient's condition, and the delirium status of the patient is evaluated through the ICDSC questionnaire every day. Intervention 2: Intervention group: The group receiving haloperidol manufactured by Exir pharmaceutical company will start intravenously at a minimum dose of 2mg/day and will be injected up to a maximum dose of 6 mg/day. Yes - There is a plan to make this available What will be shared: Age, sex, treatment protocol, response to treatment, and answers to two ICDSC and RASS questionnaires can be accessed for each participant without mentioning personal information. When: Access has been started since 2024 To whom: Researchers working in academic and scientific institutions Conditions: By mentioning the source, it can be used for researchers. Where to obtain: Dr Hajar Salimi Address: Khurshid Hospital, Department of Psychiatry Landline: 03132222475 Mobile phone: 09133285298 salimi85ha@gmail.com How to obtain: Sending an e-mail requesting access to information to the main presenter (Ms. Dr. Salimi) Comments:
public AhmadReza Aghabozorgi
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Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 aghabozorgi.ahmadreza@gmail.com Esfahan University of Medical Sciences scientific Ahmadreza Aghabozorgi
Isfahan, Hazarjarib St
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 aghabozorgi.ahmadreza@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are diagnosed with delirium based on DSM5 criteria. Patients who have not received non-pharmacological treatments to control symptoms. 5≤ICDSC و RASS≥+1 Not being intubated or extubated for more than 24 hours Hospitalization in ICU for non-surgical reasons 18 years no limit Both Patients who receive drugs other than dexmedetomidine or haloperidol for the treatment of delirium (such as other antipsychotics and midazolam) Receiving dexmedetomidine or haloperidol within 72 hours before entering the study Patients with a history of drug sensitivity to dexmedetomidine or haloperidol. Patients with a history of long QTc (<500 ms) Patients with dementia, Parkinson's, malignant neuroleptic syndrome, patients with a history of major psychiatric disorders such as bipolar and schizophrenia, addiction to various drugs and stimulants. Women during breastfeeding and pregnancy Unwillingness of the patient or family to participate in the study Severe forms of vision and hearing F05 Delirium due to known physiological condition Treatment - Drugs Treatment - Drugs In the group receiving dexmedetomidine manufactured by Exir pharmaceutical company, the drug is administered intravenously with a starting dose of 0.5 μg/kg per hour. To achieve the effect of the drug, at least one hour of injection is required. Therefore, after one hour, the patient is evaluated through the RASS questionnaire, and if a score of zero is obtained, the drug is continued with the same dose for 72 hours, and the RASS questionnaire is administered every hour for 6 hours and then every 12 hours until the end of 72 hours from the start of the intervention. will be completed If after the injection with the initial dose, a score higher than zero is obtained in the RASS questionnaire, the injection is continued with a dose of 0.8 μg/kg per hour, and the assessment of the patient's condition is carried out in the same order as mentioned above.If the patient's agitation is not controlled with this dose (a score of zero in the RASS questionnaire means a suitable response to the treatment), in the next step, the drug is injected at a dose of 1.2 μg/kg per hour. If the agitation is not controlled with this dose, The result is considered as the ineffectiveness of the drug in controlling the patient's symptoms, and other drugs are used according to the patient's condition, and the delirium status of the patient is evaluated through the ICDSC questionnaire every day. Intervention group: The group receiving haloperidol manufactured by Exir pharmaceutical company will start intravenously at a minimum dose of 2mg/day and will be injected up to a maximum dose of 6 mg/day. Mean score of ICDSC questionnaire. Timepoint: Intensive care Delirium Screening checklist (ICDSC) will be evaluated for daily delirium evaluation for up to 3 days. Method of measurement: Intensive care Delirium Screening checklist (ICDSC). Mean SCORE OF RASS QUESTIONNAIRE. Timepoint: After the intervention, every hour to 6 hours, then every 1 hour to 3 days. Method of measurement: Richmond Agitation Sedation Scale (RASS). Delirium intensity. Timepoint: From the time of intervention (drug prescription) daily for 3 days. Method of measurement: Patient's clinical status. ICDSC and RASS questionnaires for patients at specified intervals and results were obtained. Timepoint: Every one hour to six hours after starting the medicine and then continue every six hours to seventy two hours. Method of measurement: Richmond Agitation Sedation Scale (RASS) scoring system and also Intensive care Delirium Screening checklist (ICDSC). Esfahan University of Medical Sciences Approved 2022-06-15 Ethics committee of Isfahan University of Medical Sciences Isfahan. Hezar Jerib Street, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)