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)

Investigating the effect of Fentanyl-Magnesium sulfate and Fentanyl-Midazolam on hemodynamic status and sedation rate

The clinical trial, with parallel groups, triple-blind, randomized, phase 2 on 40 patients. Random allocation software will be used for randomization.

This is a triple-blind randomized clinical trial conducted on 40 patients admitted to the ICU of Al-Zahra Hospital, Isfahan. After the approval of the ethics committee and obtaining consent, if the entry criteria exist, patients will be randomly assigned to the groups, the desired intervention will be applied, and the symptoms will be recorded. The researcher who records the patient's symptoms is different from the clinical caregiver who applies the intervention, the patient's guardians, and the data analysts also have no knowledge of the type of intervention. therefore, they are all blind.

Inclusion criteria: patients aged 18 to 75 years, admitted to the intensive care unit, requiring mechanical ventilation for at least 12 hours, and consent to enter the study. Non-entry inclusion: central nervous system disorder, use of neuromuscular blocking compounds, epidural anesthesia, history of allergy to the drugs used, tracheostomy patients, pregnant and lactating women

Intervention group A: patients receive an initial dose of 1.5 µg/kg of Fentanyl and an initial dose of 0.3 mg/kg of Midazolam as a bolus upon entering the ICU, and continue to receive the same amount of Fentanyl and Midazolam as an infusion every hour. Intervention group B: patients receive an initial dose of 1.5 µg/kg of Fentanyl as a bolus upon entering the ICU, followed by 1.5 µg/kg of Fentanyl and 2 grams of Magnesium Sulfate as an intravenous infusion every hour for 6 hours.

Changes in hemodynamic status, degree of sedation

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.

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.