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IRCT20230101057010N1 IRCT 2023-12-20 Karaj University of Medical Sciences Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with hypertension-caused ICH and IVH Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with non-traumatic ICH and IVH caused by hypertension in patients admitted to the ICU 2023-12-22 anticipated 68 Complete https://irct.ir/trial/68057 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 68 intubated patients suffering from non-traumatic ICH and IVH caused by hypertension who were admitted to the ICUs of Shahid Madani Hospital in Karaj in 2023 were selected for the study, and with the help of rand function of Excel software we randomly divide the individual into two groups: midazolam and dexmedetomidine (34 people each), Blinding description: Patients and their legal guardians are included in the study without knowing the type of sedative drug. Also, those responsible for data collection will be unaware of the type of medication the patient received, and the medication will only be known to the attending physician and ICU nurses. 4 Nontraumatic intracranial hemorrhage. Intervention 1: Intervention group: Dexmedetomidine: This drug is a selective alpha-2-adrenoceptor agonist that can calm patients hospitalized in ICU and is available in 100MCG/2ML vials. Patients in this group will receive an infusion of 0.5 mg/kg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 0.2 to 0.5 mg/kg per hour based on the amount of sedation. Intervention 2: Intervention group: Midazolam: This drug is a relatively short-acting benzodiazepine drug that has anti-anxiety and sedative effects and can calm patients hospitalized in ICU, and in this study, 5mg/1ml ampoules of this drug will be used. Patients in this group will receive an infusion of 2 mg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 1 to 2 mg per hour based on the amount of sedation. Yes - There is a plan to make this available What will be shared: All potential data, including the data file of the participants, the informed consent form, and the study protocol will be shared after de-identifying people, according to the protocols of Alborz University of Medical Sciences. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The data of this study will be available to perform analyzes related to the safety and efficacy of the investigated drugs. Where to obtain: Dr. Sevak Hatmian How to obtain: The information will be accessible after being reviewed by the research vice-chancellor of Alborz University of Medical Sciences Comments:
public Misagh Rostami
Shahid Madani Hospital , Mahan Ave , Shahid Taleghani Ave
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3442 7001 misagh.rostami1988@gmail.com Karaj University of Medical Sciences scientific Sevak Hatamian
Shahid Madani Hospital , Mahan Ave , Shahid Taleghani Ave
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3442 7001 misagh.rostami1988@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) ICH or IVH due to high blood pressure ICU admission Patient intubation be at least 18 years old Consent of the patient or legal guardian in terms of entering the study 18 years no limit Both A heart rate of less than 60 is excluded from the study after receiving atropine. If the patient is not sedated with the maximum dose of midazolam and dexmedetomidine (Ramsay Sedation Scale above 4), the patient will be prescribed narcotics and will be excluded from the study. MAP less than or equal to 7 Lack of consent of the patient or legal guardian I62.9 Nontraumatic intracranial hemorrhage, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Dexmedetomidine: This drug is a selective alpha-2-adrenoceptor agonist that can calm patients hospitalized in ICU and is available in 100MCG/2ML vials. Patients in this group will receive an infusion of 0.5 mg/kg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 0.2 to 0.5 mg/kg per hour based on the amount of sedation. Intervention group: Midazolam: This drug is a relatively short-acting benzodiazepine drug that has anti-anxiety and sedative effects and can calm patients hospitalized in ICU, and in this study, 5mg/1ml ampoules of this drug will be used. Patients in this group will receive an infusion of 2 mg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 1 to 2 mg per hour based on the amount of sedation. Agitation level. Timepoint: It will be measured and recorded at different times, including upon arrival, the first 30 minutes after entering the ICU, and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours, and 24 hours after entering the ICU. Method of measurement: Ramsay Sedation Scale. Vital sign. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Blood pressure measuring device, pulse oximeter, thermometer. The need to use narcotic drugs to maintain sedation. Timepoint: Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded. Method of measurement: Ramsay Sedation Scale. Karaj University of Medical Sciences Approved 2023-10-07 alborz university of medical sciences Taleghani Blvd Karaj Alborz Iran (Islamic Republic of)