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IRCT20220424054631N1 IRCT 2022-05-14 Oroumia University of Medical Sciences Comparative effect of Lorazepam with Midazolam in sedative of patients under mechanical ventilatin hospitalized Comparative effect of Lorazepam with Midazolam in sedative of patients under mechanical ventilatin hospitalized in Intensive care unit of Imam Khomeyni Hospital 2022-04-30 anticipated 110 Complete https://irct.ir/trial/63190 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization method: simple Registration of patients and their assignment in each group by An anesthesiologist and a person other than the person performing the project are performed Randomization unit: individual Random tool: statistical software Random allocation will be hidden in such a way that the assigned group is not known before the individual is assigned, Blinding description: This study is a double-blind clinical trial and the patient and the intern do not know the type of drug received for sedation. 3 Patients under mechanical ventilation admitted to the intensive care unit. Intervention 1: Intervention group: Group L patients will receive 2 mg of lorazepam every 2 hours for 12 hours (12 mg). The drug will be diluted and infused in 250 cc of normal saline 0.9%. Intervention 2: Intervention group: Group M patients will receive midazolam at a dose of 2 mg per hour for 12 hours (24 mg), the drug will be diluted and infused in 250 cc of normal saline 0.9%. Yes - There is a plan to make this available What will be shared: How to do the project and its final results will be published When: Access will start 3 months after the results are published To whom: The data will be available to the public Conditions: Based on the results and data, the type of sedative for patients can be decided Where to obtain: Amin Nourollahi executor of plan Email: Amin1816@yahoo.com How to obtain: The project and the data will be published in the form of articles. Researchers can have the necessary access by searching among the published articles. Comments:
public Mohamadamin Valizadeh Hasanloui
Imam Khomeini Hospital, Ershad St
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3348 5325 aminvalizade@yahoo.com Oroumia University of Medical Sciences scientific Mohamadamin Valizadeh Hasanloui
Imam Khomeini Hospital, Ershad St
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3348 5325 aminvalizade@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Pulmonary patients under mechanical ventilation with appropriate level of consciousness (equivalent to GCS≥10) Age 18-65 years Patients who have not received benzodiazepines in the last 72 hours 18 years 65 years Both Patients with inadequate level of consciousness GCS <10 Patients with unstable hemodynamics Allergy to benzodiazepines or contraindications to the use of benzodiazepines Age under 18 or over 65 years Patients with neurological disorders, kidney or liver failure Patients who have recently received or are dependent on long-acting benzodiazepines Treatment - Drugs Treatment - Drugs Intervention group: Group L patients will receive 2 mg of lorazepam every 2 hours for 12 hours (12 mg). The drug will be diluted and infused in 250 cc of normal saline 0.9%. Intervention group: Group M patients will receive midazolam at a dose of 2 mg per hour for 12 hours (24 mg), the drug will be diluted and infused in 250 cc of normal saline 0.9% Comparison of the sedative effect of lorazepam with midazolam. Timepoint: Patients will be assessed at injection start times of 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: During current study patients' demographic information (age and sex), body mass index, blood pressure, heart rate, respiratory rate, oxygen saturation( via pulse oximetry), level of consciousness (by Glasgow coma scale) and level of sedation ( by Richmond sedation scale and Ramsay sedation scale) will be recorded in a checklist prepared by the researcher. Also, the total amount of midazolam and lorazepam that will be used, their prices, duration of mechanical ventilation, duration of hospitalization ( either in intensive care unit or ward) and the mortality rate of patients will be recorded. Richmond benchmark score. Timepoint: Patients will be evaluated at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: - Aggressive, aggressive (fierce, militant, with violent and dangerous movements for themselves and others) +4- Very restless (aggressive, restless, kills tubes and catheters, dangerous for himself) +3- Restless (repetitive movements, aimless, fighting with mechanical ventilation) +2- Restless (has worries and fears, excited; but not aggressive and restless) +1- Calm-conscious (with normal movements and behavior) 0- Sleepy - confused (not fully awake but can stay awake for more than 10 seconds (make eye contact against sound for more than 10 seconds)) 1-- Slightly mild (slight (mild) drowsiness stays awake for less than 10 seconds (making eye contact against sounding less than 10 seconds)) 2-- Medium calm (opens his eyes, moves in the direction of sound but without eye contact) 3-Intense calm (does not respond to sound, but responds to the therapist's physical stimuli)- No response (does not respond to the therapist's voice and physical stimuli) 5-. Ramsay scoring system. Timepoint: Patients will be evaluated at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: Can not be assessed 0 is fully conscious 1 is drowsy, wakes up without stimulus 2 is drowsy, who wakes up with vocal stimulation 3 is drowsy and wakes up with a bang on the shoulder and loudly 4 is drowsy and wakes up with a bang on the face and a loud voice 5 is drowsy and does not respond to blows to the face and loud voice. Glasgow Index. Timepoint: Patients will be evaluated at baseline and 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after infusion. Method of measurement: An index to report the severity of anesthesia in a person with a score of 4 to 15. Body mass index. Timepoint: Start studying. Method of measurement: بر حسب Kg/m2. Cause of intubation. Timepoint: Start studying. Method of measurement: Surgery, hypoxia, hypercapnia, etc. Cause of admission. Timepoint: Start studying. Method of measurement: Reason for patients to refer to the intensive care unit. Type of medicine. Timepoint: End of study. Method of measurement: One of the two drugs lorazepam and midazolam will be injected for the patient. Cost of medicine. Timepoint: End of study. Method of measurement: Rial. Side effects. Timepoint: Patients will be evaluated at 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, and 12 hours after the start of the infusion. Method of measurement: Forgetfulness, headache, excessive lethargy, pain, sleepiness, hypotension, pain and tenderness at the injection site, apnea, cough, slow breathing, hiccups, respiratory arrest, etc. Duration of mechanical ventilation. Timepoint: Since intubation. Method of measurement: By day. Mortality rate. Timepoint: End of study. Method of measurement: Died, alive. Oroumia University of Medical Sciences Approved 2022-03-15 Ethics Committee of Urmia University of Medical Sciences Corner of the alley 8, in front of the health center, Kashani St urmia West Azarbaijan Iran (Islamic Republic of)