Assessment of the thiamine effect on post-operative delirium occurrence in patients undergoing hip surgery in intensive care unit

Determining the effect of thiamine on the occurrence of postoperative delirium in patients undergoing hip surgery in the intensive care unit

Patients over 60 years of age and ASA classes I to III who are candidates for hip and proximal femur fracture surgery were randomized into two groups (60 people in the group receiving thiamine (T) and 60 people in the control group receiving placebo (C)) will be divided.

Patients over 60 years of age hospitalized in the special care department of Imam Khomeini Hospital in Urmia who underwent hip surgery and had a previous history of any neuropsychological disorder, severe renal failure, severe liver failure, drug or alcohol abuse, diabetic ketoacidosis, and patients with a history of delirium do not have Demographic and clinical information, duration of anesthesia, recovery time, medications taken, under mechanical ventilation, evaluation of acute physiological problems and chronic health grade II at the time of admission, and daily evaluation of organ failure will be recorded consecutively. Patients will be divided into two equal groups.

Patients over 60 years old who are hospitalized in the intensive care unit after hip surgery,Failure to enter: patients with a history of mental disorders Severe renal failure Severe liver failure Drug or alcohol abuse Diabetic ketoacidosis History of delirium

In the intervention group, a 300 mg vitamin B1 thiamine pill will be taken daily for three days, and in the control group, a placebo will be provided daily for 3 days with the same color and appearance as thiamine from Karen Pharmaceutical Company, Karen Vital Food Supplements.

Prevent delirium

Sampling will be done by the random permutation block design method of two treatments with 5 blocks. First, 5 blocks of the composition (ABABA) will be listed and a code will be assigned to each, then according to the sample size equal to 55, 11 blocks will be selected in this order that the letter A for the group Thiamine and letter B will be considered for the control group receiving placebo. 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 5 capacities. Based on the example of ABABA, 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 the thiamine group (55 people) or the placebo control group (B) (55 people). In this study, randomization will be simple, in a box the numbers 1 to 55 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 placed in the first group, and if it is an odd number, it will be in the second group.

All the codes are secret and the examiner will be a doctor outside the research team responsible for delirium evaluation and they will not be informed about the grouping of people. Both the patients are unaware of the delirium group they are in, and the doctor responsible for delirium assessment will not know the patient group. A placebo with the same color and appearance as thiamine will be prepared and assigned by the pharmaceutical department. Finally, after collecting the data of each group separately, they will be compared by the evaluator doctor who does not know about the patient group. The primary outcome of the study will be the incidence of delirium after surgery.