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IRCT20160307026950N44 IRCT 2022-09-08 Esfahan University of Medical Sciences Investigating the effect of the combination of Fentanyl-Magnesium sulfate and Fentanyl-Midazolam on hemodynamic status and sedation rate Comparison of the effect of Fentanyl-Magnesium sulfate and Fentanyl-Midazolam combination administration on hemodynamic status and sedation rate of patients undergoing mechanical ventilation in Intensive Care Unit (ICU) 2022-09-23 anticipated 40 Complete https://irct.ir/trial/65128 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number, Blinding description: This is a Triple-blind clinical trial; In this way, the researcher who records the patient's symptoms is different from the nurse who injects the drug and does not know the type of drug and is blind. The analysts who analyze the data collected during the study also know the type of intervention. It does not exist in any group and is blind. Even though the patient's guardians are included in the study, they do not know the type of intervention and are blind. 3 Mechanical ventilation in the ICU. Intervention 1: Intervention group A: In this group, patients are examined in terms of disease severity and hemodynamic status upon entering the ICU, and their vital signs are recorded. Then 1.5 µg/kg initial dose of Fentanyl manufactured by Caspian Company and 0.3 mg/kg initial dose of Midazolam manufactured by Aburihan Company will be received as a bolus, and then they will receive the same amount of Fentanyl and Midazolam as an infusion every hour. The condition and symptoms of the patient are checked and recorded for up to 24 hours. Intervention 2: Intervention group B: In this group, patients are examined for the severity of the disease and hemodynamic status upon entering the ICU, and their vital signs are recorded. Then they receive an initial dose of 1.5 µg/kg of Fentanyl as a bolus and continue every hour. They receive 1.5 µg/kg of Fentanyl and 2 g of Magnesium Sulfate as intravenous infusion for 6 hours. The condition and symptoms of the patient are checked and recorded up to 24 hours. 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 more information
public Sahar Meraatian
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 shr.mrttin@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 75 years Bedridden in ICU Requires mechanical ventilation for at least 12 hours Consent to participate in the study 18 years 75 years Both Central nervous system disorders Weight more than 120 kg Use of neuromuscular blockers General or regional anesthesia allergy to the drugs used Tracheostomy patients pregnant and breastfeeding women Diagnosis Diagnosis Intervention group A: In this group, patients are examined in terms of disease severity and hemodynamic status upon entering the ICU, and their vital signs are recorded. Then 1.5 µg/kg initial dose of Fentanyl manufactured by Caspian Company and 0.3 mg/kg initial dose of Midazolam manufactured by Aburihan Company will be received as a bolus, and then they will receive the same amount of Fentanyl and Midazolam as an infusion every hour. The condition and symptoms of the patient are checked and recorded for up to 24 hours. Intervention group B: In this group, patients are examined for the severity of the disease and hemodynamic status upon entering the ICU, and their vital signs are recorded. Then they receive an initial dose of 1.5 µg/kg of Fentanyl as a bolus and continue every hour. They receive 1.5 µg/kg of Fentanyl and 2 g of Magnesium Sulfate as intravenous infusion for 6 hours. The condition and symptoms of the patient are checked and recorded up to 24 hours. The amount of sedation. Timepoint: Every hour to 24 hours. Method of measurement: Richmond Anxiety-Sedation Scale. Pain amount. Timepoint: Every hour to 24 hours. Method of measurement: Visual Analogue Scale. Blood Pressure. Timepoint: Every hour to 24 hours. Method of measurement: Sphygmomanometer. Heart Rate. Timepoint: Every hour to 24 hours. Method of measurement: Electrocardiogram. Esfahan University of Medical Sciences Approved 2022-05-20 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)