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IRCT20211208053328N2 IRCT 2022-07-30 Esfahan University of Medical Sciences Evaluation of efficacy and safety of furosemide in transurethral prostate resection in reducing postoperative hyponatremia : a randomized controlled trial Evaluation of efficacy and safety of furosemide in transurethral prostate resection in reducing postoperative hyponatremia : a randomized controlled trial 2022-08-06 anticipated 70 Complete https://irct.ir/trial/63845 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly in the case or control group by www.randomizer.org, so that the patient's number between 70 patients will be in the two categories, including category 1 as the case group and the 2 as the control group. Then, based on the order of the operation and categorization, these patients will be in one of these groups, Blinding description: The patient will be blinded in terms of the drug administration. Envelopes including the study group, will be given to the anesthesiologist outside of the operating room before the anesthesia induction so that the drug can be injected if the patient was in the relevant group. The data collector is not aware of it, so he will be blinded. The data analyzer will not be aware of the study group. 2 Hyponatremia after TURP surgery. Intervention 1: Intervention group: Immediately before the anesthesia induction, they will receive intravenous 40 mg of furosemide (Ampule Lasix, 40mg/4ml, Sanofi, India). This group also receives the necessary anesthetic measures as routine. Intervention 2: Control group: Without Furosemide (Ampule Lasix, 40mg/4ml, Sanofi, India). This group receives the necessary anesthetic measures as routine. No - There is not a plan to make this available Justification or reason for not sharing IPD is Information is kept confidential
public Hossein Bahrami Samani
Alzahra hospital, Sofeh Blv.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Bahrami.hossein1993@gmail.com Esfahan University of Medical Sciences scientific Hossein Bahrami Samani
Alzahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 bahrami.hossein1993@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients have standard indication for TURP (Transurethral resection of the prostate)(frequent urinary retention, bilateral hydronephrosis with the probability of kidney damage, frequent urinary tract infection because of high post-void residual, Gross and severe hematuria, severe urinary symptoms in BPH (benign prostatic hyperplasia) that is resistant to treatment) Normal renal function (Normal blood urea nitrogen and creatinine) no limit no limit Male Z48. 816 Encounter for surgical aftercare following surgery on the genitourinary system Treatment - Other N/A Intervention group: Immediately before the anesthesia induction, they will receive intravenous 40 mg of furosemide (Ampule Lasix, 40mg/4ml, Sanofi, India). This group also receives the necessary anesthetic measures as routine. Control group: Without Furosemide (Ampule Lasix, 40mg/4ml, Sanofi, India). This group receives the necessary anesthetic measures as routine. Sodium level of the serum. Timepoint: Before surgery, one hour after surgery and 24 hours after surgery. Method of measurement: Audicom AC9800 Automatic Electrolyte Analyzer. Potassium level of the serum. Timepoint: Before surgery, one hour after surgery and 24 hours after surgery. Method of measurement: Audicom AC9800 Automatic Electrolyte Analyzer. Creatinine level of the serum. Timepoint: Before surgery, one hour after surgery and 24 hours after surgery. Method of measurement: Creatinin Jaffe kit, Biorexfars company. Esfahan University of Medical Sciences Approved 2022-03-31 Ethics committee of Isfahan University of Medical Sciences Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)