Comparison of the effect of intravenous selenium and magnesium sulfate on the clinical outcomes of patients with severe traumatic brain injury in the intensive care unit.

Determining and comparing the effect of intravenous selenium and magnesium sulfate on the clinical outcomes of patients with severe traumatic brain injury in the intensive care unit.

A double-blind clinical trial with parallel groups, randomized phase 1-2 of two selenium groups and magnesium sulfate group on 110 patients in randomized blocks of two treatments

This clinical trial will include two patients with blunt trauma who have a level of consciousness score of more than 3 to 8 referring to Imam Khomeini Hospital in Urmia. Patients in two groups, one group received selenium 500 µg intravenously as a bolus within 30 minutes, and then 500 µg as a 24-hour intravenous infusion for 14 consecutive days, and the other group received magnesium sulfate for 14 days, treated twice a day with magnesium sulfate at the rate of 500 will receive μmol/kg. In terms of magnesium toxicity, magnesium levels will be checked daily. Glasgow Outcome Scale (GOS) will be determined daily and at discharge for each patient.

Patients with blunt trauma who have a consciousness level score of more than 3 to 8 and the written consent form of participation in the research project has been signed by the patient's first degree relatives . People with end-stage chronic disease, known cases of kidney, liver and heart failure.

In one group, Selenium was given 500 µg intravenously as a bolus within 30 minutes, and then 500 µg as a 24-hour intravenous infusion for 14 consecutive days, and the other group was treated with magnesium sulfate for 14 days twice a day with magnesium sulfate at the rate of 500 µmol/ kg

Unfavorable outcomes (death, vegetative life, severe disability and moderate disability) and favorable outcome (good recovery)

Patients will be randomly assigned to two groups A and B using Random Allocation computer software. By selecting the simple randomization method in the randomization method section and entering the total sample size determined in this software, numbers will be given to the patients and the patients will be entered into two groups based on the numbers given by the computer. Randomization will be done based on the permuted block randomization method. Each block will have 10 capacities. Based on the example of ABABABABAB, in each block, people are evenly assigned to two groups. 11 blocks will be built. After that, in each block, people are randomly assigned to selenium group (A) (55 people) or magnesium sulfate group (B) (55 people). In this study, randomization will be simple, in a box the numbers 1 to 110 will be written on sheets of paper and placed inside the box in an unspecified manner. One sheet will be removed for each disease if the number is even. It will be in the first group, and if it is an odd number, it will be in the second group.

The study will be double-blind, the patient, the anesthesiologist, and the surgeon will not know which group each patient belongs to. The syringes will be identical in appearance. Finally, after collecting the data of each group separately, they will be compared by the clinical assessor - who does not know about the patient group.