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IRCT20211015052773N1 IRCT 2021-11-05 Artesh University of Medical Sciences Efficacy and safety of Clonidine vs Alprazolam in sedating covid-19 ICU patients Efficacy and safety of Clonidine vs Alprazolam in reducing anxiety of Covid-19 patients in the Intensive Care Unit 2021-11-05 anticipated 100 Complete https://irct.ir/trial/59368 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into clonidine and alprazolam receiving groups with simple random method by using the random number table. The random number function was used to randomize and assign individuals to groups; Randomization using Excel software is as follows: First, in a column, the groups are entered as A, B and below each other; because the number of samples in each group is set to 35 (taking into account the sample loss), 35 A and 35 B must be entered in order and below each other. In the opposite column, random numbers are generated using the RAND command. In the next step, with using the sort command, random numbers are generated from small to large or vice versa, which causes the order of the groups A and B to be changed. In fact, using the new order, individuals are randomly assigned to the case and control groups, Blinding description: This is a double blinded study means that patients are not aware of the exact drugs that is being prescribed for them and they just know that in this study they are going to receive Alprazolam or Clonidine. drug boxes' will not be shown to the patients even we will use similar drug shapes and the shape of the tablets of Clonidine and Alprazolam are same to patients can not recognize the exact type of drugs. one of the researchers will prescribe Alprazolam or Clonidine according to random number table results. another researchers will collect the clinical results without knowing which drugs has been prescribed for each patients. 3 anxiety in ICU admitted COVID-19 patients. Intervention 1: Intervention group: 0.5 mg Alprazolam tablet (Abidi company) start from the date of admission until death or clearance. Intervention 2: Intervention group: 0.1 mg Clonidine tablet (Tolidaroo Company) start from the date of admission until death or clearance. 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 No more info
public Mohammad Bagheri
5th unit- no25- Safavian alley, Tehranvilla St. Sattarkhan St
Tehran Iran (Islamic Republic of) 1444783846 +98 21 6650 2417 mohammadbagheri@lotusmedco.com Artesh University of Medical Sciences scientific Mohammad Bagheri
No 25, Safavian alley, Tehranvilla St. Sattarkhan St
Tehran Iran (Islamic Republic of) 1444783846 +98 21 6650 2417 mohammadbagheri777@sbmu.ac.ir Artesh University of Medical Sciences Iran (Islamic Republic of) COVID -19 disease with positive PCR test ICU admission consciousness 18 years 80 years Both unconsciousness and GCS reduction heart rate below 50 bps DPB below 60mmhg SBP below 90mmhg second degree AV block and over Delirium during admission F06.4 Anxiety disorder due to known physiological condition Treatment - Drugs Treatment - Drugs Intervention group: 0.5 mg Alprazolam tablet (Abidi company) start from the date of admission until death or clearance Intervention group: 0.1 mg Clonidine tablet (Tolidaroo Company) start from the date of admission until death or clearance Anxiety level score in numeral verbal rating scale. Timepoint: daily from the date of addition until clearance or death. Method of measurement: anxiety numeral verbal rating scale. Hypotention. Timepoint: each 6 hours from the date of admission until clearance or death. Method of measurement: mercury manometer. Bradycardia. Timepoint: each 6 hours from the date of admitting until clearance or death. Method of measurement: radial pulse checking. Delirium. Timepoint: daily from the date of admission until death or clearance. Method of measurement: Diagnostic and Statistical Manual of Mental Disorders guideline, 5th Edition. Artesh University of Medical Sciences Approved 2021-09-26 Ethics committee of AJA university of medical sciences 5th unit-no25- Safavian alley, Tehranvilla St, Sattarkhan St. Tehran Tehran Iran (Islamic Republic of)