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IRCT20211022052838N1 IRCT 2023-06-21 Esfahan University of Medical Sciences Comparison between sedating effect of Midazolam and Dexmedetomidine in intubated poisoned patients Comparison of the sedation effect of Dexmedetomidine and midazolam using the Richmond agitation sedation scale (RASS) in patients admitted to clinical toxicology intensive care unit 2023-06-22 anticipated 60 Complete https://irct.ir/trial/69440 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random allocation of eligible people into two groups is done by Random allocation software. There are several boxes in this software: the number of groups, the total number of samples. After specifying the number of groups (2) and the total number of samples (60), the software randomly divides the entire sample into two groups of 30, Blinding description: According to the randomization done by the software, the main author of the plan (professor) knows which patient will take which of the drug categories and injects the ampoule containing the sedative drug to the patient, while the patient does not know which of the two drugs, has received. Then the outcome assessor (student) comes to the patient's bedside and fills the RASS form without knowing what medicine the patient has taken. Then the information and forms are provided to the data analyst without knowing which medicine the patient has received, and after the analysis, he provides the information to the main author of the plan. 3 Sedation before Intubation. Intervention group: Patients admitted to Intensive care unit (ICU) of poisoned patients. 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 There is no further information"
public Arman Otroshi
Elahie apartment. No2 avenue. No9 Street.shahed Blvd. Sepahan Shahr .Isfahan
Isfahan Iran (Islamic Republic of) 0000000000 +98 31 3651 4261 arman_otroshi@yahoo.com Esfahan University of Medical Sciences scientific Arman Otroshi
Elahie apartment. No2 avenue. No9 Street.shahed Blvd. Sepahan Shahr .Isfahan
Isfahan Iran (Islamic Republic of) 0000000000 +98 31 3651 4261 Arman_otroshi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with American society of anesthesiologist (ASA) class 3 and 4 who are admitted in ICU of poisoned patients Age between 18 to 80 Patients whom are going to be intubated Not taking sedative drugs before admitting to intensive care unit (ICU) 18 years 80 years Both known allergy to any of the drugs used in this study advanced liver disease Serum creatinine level above 200 micromol/liter Unstable angina or acute myocardial infarction patients Treatment - Other Intervention group: Patients admitted to Intensive care unit (ICU) of poisoned patients The amount of sedation caused by drug according to RASS scale. Timepoint: Before intervention and then every 2 hours. Method of measurement: RASS scale system is a known scale in the world that measured the rate of sedation whom admitted to ICU. Scoring points in this scale include -5 to +4 that the +4 point belongs to agitated and aggressive patients who are a threat for ICU personals. the -5 points belongs to the patients who are not responding to voice and physical stimulations and they are not conscious. the rest of points are spectrum between these two scores. Blood pressure in the admitted patients of ICU. Timepoint: Before intervention and then every 2 hours. Method of measurement: Vital sign monitoring device. Heart rate. Timepoint: Before intervention and then every 2 hours. Method of measurement: Vital sign monitoring device. Esfahan University of Medical Sciences Approved 2023-04-04 Ethics committee of Isfahan university of medical sciences Isfahan university of medical sciences, isfahan Isfahan Isfehan Iran (Islamic Republic of)