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IRCT20241108063640N1 IRCT 2024-11-13 Oroumia University of Medical Sciences Comparison of normal saline with Ringer's serum on Venus blood Gas (VBG( changes in inguinal hernia surgery patients under spinal anesthesia Comparison of normal saline with Ringer's serum on Venus blood Gas (VBG( changes in inguinal hernia surgery patients under spinal anesthesia 2024-12-20 anticipated 70 Complete https://irct.ir/trial/80077 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Determination and comparison of normal saline with Ringer's serum on venous blood gas changes in inguinal hernia surgery patients under spinal anesthesia, Randomization description: 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 7 capacities. 5 blocks will be built based on the example of ABABABA, where in each block, people are evenly assigned to two groups. After that, in each block, people are randomly assigned to the normal saline group (A) (35 patients) or the Ringer's serum group (B) (35 patients). In this study, randomization will be simple, in a box, the number 1 to 70 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 the number is odd, it will be in the second group, Blinding description: The method of blinding will be such that only the anesthesiologist will be aware of the serum being injected and the type of intraoperative fluids given will be hidden from the patients, surgeons and laboratory technicians involved in the study. N/A Inguinal hernia surgery patients under spinal anesthesia. Intervention 1: Intervention group: Patients in the NS group will receive only NS serum before spinal anesthesia as a bolus of 500 cc and during surgery as a bolus of 20 cc per kilogram of body weight. Intervention 2: Intervention group: Ringer group R patients will receive 500 cc bolus before spinal anesthesia and 20 cc per kilogram of body weight as crystalloid only. 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 will make a decision to publish after the completion of the project and according to the results
public Dr.Hadi Hooshyar
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 hooshyarhadi@gmail.com Oroumia University of Medical Sciences scientific Dr.Hadi Hooshyar
Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd- Urmia
Urmia Iran (Islamic Republic of) 5715789397 +98 44 3346 9931 hooshyarhadi@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age over 18 years and under 85 years Physical status ASA I, II Patients undergoing inguinal hernia repair surgery 18 years 85 years Male Bilateral hernias Emergency inguinal hernia repair operations Renal failure patients Adrenal failure patients patients with heart and lung diseases K40 Inguinal hernia Treatment - Drugs Treatment - Drugs Intervention group: Patients in the NS group will receive only NS serum before spinal anesthesia as a bolus of 500 cc and during surgery as a bolus of 20 cc per kilogram of body weight. Intervention group: Ringer group R patients will receive 500 cc bolus before spinal anesthesia and 20 cc per kilogram of body weight as crystalloid only. Assessment of changes in venous blood gases. Timepoint: After administration of normal saline and Ringer's serum. Method of measurement: Immediately at the end of the surgery, the blood sample will be collected again and will be sent to the laboratory to check sodium and potassium levels and venous blood gases. Oroumia University of Medical Sciences Approved 2024-10-22 Ethics Committee of Imam Khomeini Hospital Imam Khomeini University Hospital-Ershad AVE-Modarres Blvd Urmia West Azarbaijan Iran (Islamic Republic of)