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IRCT20110425006280N13 IRCT 2021-08-14 Vice President of Research Guilan university of medical sciences Evaluation of the effectiveness of dexmedetomidineine sedation of COVID-19 critically ill patients Evaluation of the effectiveness of dexmedetomidine in sedation of COVID-19 critically ill patients hospitalized in the intensive care unit , A double blind clinical trial 2021-08-23 anticipated 60 Complete https://irct.ir/trial/57618 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be randomly assigned to each of the two groups (control or intervention) using block randomization with a ratio of 1:1. 60 of the critically ill COVID-19 patients will be divided into two groups of 30.Intervention and control groups will be called A and the control group will be named B.Random blocking will be assigned to research units in numbers 1-30, respectively. Then a table with 6 rows called blocks and each block will have 4 parts and each part will be named with A and B, will be considered.In the next step, the numbers are placed in each house in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group, Blinding description: Each patient's group therapy will be determined only after randomization. Participants and physicians responsible for caring for patients' health will not be blinded and will be informed of the treatment group. Radiologists, researchers evaluating research and statisticians will be blind to the treatment group of patients. 3 The effect of dexmedomedine in COVID-19 patients.. Intervention 1: Intervention group consists of 30 patients, which will recieve the standard regimen of COVID-19 treatment including ramdisvir, interferen and corticosteroids and supplements in addition to dexmedtomidine for sedation. Dexmedtomidine is produced by Elixir Pharmaceutical Company, which is in form of a 200 Micrograms in a 2 millilitres vial. The total time of this study will be 15 days. Evaluation of clinical status of patients will be on 8-hour intervals, based on questionnaire form and variables of the study . Intervention 2: Control group: consists of 30 patients,who will receive standard treatment of COVID-19 mentioned as above plus standard sedative treatment regimen which is a fentanyl and morphine pump,including a vial of fentanyl and a vial of morphine and will be injected at a speed of 3-5 millilitre per hour based on the patients need for relaxation. 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 It is not yet known if there will be a plan to make this available
public Mohammad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
Rasht Iran (Islamic Republic of) 4193713194 +98 13 1322 3970 manesthesist@gmail.com Guilan University of Medical Sciences scientific Mohammad Haghighi
Razi Hospital, Sardar Jangal Street, Rasht
rasht Iran (Islamic Republic of) 4193713194 +98 13 1322 3970 manesthesist@gmail.com Guilan University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 75 years admitted to the Intensive Care unit clinical diagnosis of respiratory distress and breathing distress Oxygen saturation less than 93% or positive polymerase chain reaction test connected to non-invasive or invasive ventilation requiring sedative administration. 18 years 75 years Both Pregnant patients Known allergies to opioid drugs or dexmedomeidine. U07.1 COVID-19,virus identified Treatment - Drugs Treatment - Drugs Intervention group consists of 30 patients, which will recieve the standard regimen of COVID-19 treatment including ramdisvir, interferen and corticosteroids and supplements in addition to dexmedtomidine for sedation. Dexmedtomidine is produced by Elixir Pharmaceutical Company, which is in form of a 200 Micrograms in a 2 millilitres vial. The total time of this study will be 15 days. Evaluation of clinical status of patients will be on 8-hour intervals, based on questionnaire form and variables of the study . Control group: consists of 30 patients,who will receive standard treatment of COVID-19 mentioned as above plus standard sedative treatment regimen which is a fentanyl and morphine pump,including a vial of fentanyl and a vial of morphine and will be injected at a speed of 3-5 millilitre per hour based on the patients need for relaxation. Clinical Symptoms of COVID-19. Timepoint: The total time of the study will be done within 15 days at 8-hour intervals. Method of measurement: questionnaire form. Relaxation of critically ill patients with 19 ICUs in terms of agitation and delirium. Timepoint: The duration of examination of patients in the ICU is 15 days. This scoring is done for patients at intervals of 8 hours and the average will be evaluated. Method of measurement: During the period of hospitalization, they will be examined for vital signs and intubation. Delirium and agitation will be assessed based on the Richmond Restlessness-Drowsiness Scale (RSAA).This scale is defined in the scoring range between 0-1.According to this scale, agitation includes items: +1 restless, +2 agitated, 3+ very agitated, +4 fighter.In the case of delirium, it is divided into 0 alert and calm, -1 drowsiness, -2 mild sedation, -3 moderate sedation, -4 deep anesthesia, and -5 absence of any awakening. Vice President of Research Guilan university of medical sciences Approved 2021-06-30 Ethical Committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)