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IRCT20150420021869N7 IRCT 2024-01-23 Esfahan University of Medical Sciences The effect of induced hypotensive anesthesia on blood loss in percutaneous nephrolithotomy Investigating the Effect of Induced Hypotensive Anesthesia versus Normotensive Anesthesia on Perioperative Bleeding in Patients Undergoing Percutaneous Nephrolithotomy: A Randomized Controlled Clinical Trial 2023-08-23 anticipated 62 Complete https://irct.ir/trial/71156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre-and post-operative assessments. The block size will be equal and is set to 4 and then the allocation code is set to sequential, Blinding description: Patients are kept uninformed about the use of controlled blood pressure during the procedure. To ensure blinding, two researchers conduct the interventions. A an anesthesiologist or resident of anesthesiology, knowledgeable about the necessary interventions for each patient, carries out the procedures while monitoring the patient's condition. Simultaneously, another researcher, unaware of the specific interventions performed on each patient, assesses blood loss and gathers necessary information through patient examinations. Additionally, the coding of the investigated groups in the collected data is implemented to maintain blinding for the statistician. 3 Calculus of kidney. Intervention 1: Intervention group: In this group, general anesthesia is administered as a standard IV injection of 4-5 mg/kg of sodium thiopental, 3 μg/kg of fentanyl and 0.15 mg/kg of cisatracurium. in this group, in addition to remifentanil anesthetic drugs, the dose of 0.2 μg/kg/min is started continuously, and then the infusion rate is changed to keep the MAP constant between 65-75 mm-hg. Intervention 2: Control group: In this group, general anesthesia is administered as a standard IV injection of 4-5 mg/kg of sodium thiopental, 3 μg/kg of fentanyl and 0.15 mg/kg of cisatracurium. Anesthesia is maintained by continuous inhalation of 60% air + 40% oxygen and 1-1.5% isoflurane, as well as intermittent bolus of 1-2 μg/kg fentanyl and 0.05 mg/kg atracurium. 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 There is no more information
public Farshad Gholipour
Hezar jarib street
Isfahan Iran (Islamic Republic of) 8168814193 +98 31 3669 7898 farshad.gholipoor@gmail.com Esfahan University of Medical Sciences scientific Farshad Gholipour
Hezar jarib street
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3668 0048 gholipour@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient candidate for percutaneous Nephrolithotomy (PCNL) Age of above 18 years 18 years no limit Both Coagulopathy Anatomical disorders that interfere with the proper positioning of the patient Any disease that makes inducing the controlled hypotension impossible during surgery Single kidney Ectopic kidney Active infection of the urinary system Pregnancy Hematological diseases Cardiovascular diseases Glomerular Filtration Rate of less than 60 cc/min N20.0 Calculus of kidney Treatment - Drugs Treatment - Drugs Intervention group: In this group, general anesthesia is administered as a standard IV injection of 4-5 mg/kg of sodium thiopental, 3 μg/kg of fentanyl and 0.15 mg/kg of cisatracurium. in this group, in addition to remifentanil anesthetic drugs, the dose of 0.2 μg/kg/min is started continuously, and then the infusion rate is changed to keep the MAP constant between 65-75 mm-hg. Control group: In this group, general anesthesia is administered as a standard IV injection of 4-5 mg/kg of sodium thiopental, 3 μg/kg of fentanyl and 0.15 mg/kg of cisatracurium. Anesthesia is maintained by continuous inhalation of 60% air + 40% oxygen and 1-1.5% isoflurane, as well as intermittent bolus of 1-2 μg/kg fentanyl and 0.05 mg/kg atracurium. Perioperative blood loss. Timepoint: Post operative. Method of measurement: After surgery, we add 1000 units of heparin to the collection bucket to prevent coagulation of the washing solution. Then 5cc of washing liquid is added to the vial of EDTA (ethylenediamine triacetic acid) to estimate hemoglobin. Hemocue method is used to estimate intraoperative bleeding. In this method, the amount of hemoglobin in the lavage fluid is multiplied by the total volume of the lavage fluid used, and the result is divided by the volume of serum hemoglobin before the operation, and thus the total amount of blood lost will be determined. Esfahan University of Medical Sciences Approved 2023-06-25 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)