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IRCT20130812014333N165 IRCT 2021-04-05 Kermanshah University of Medical Sciences Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after surgery in patients undergoing ureteral stone surgery Comparative study of hemodynamic and renal effects of Pethidine and Marcaine during and after the operation in patients undergoing TUL surgery: double-blind randomized controlled clinical trial 2021-04-18 anticipated 66 Complete https://irct.ir/trial/54165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group, Blinding description: Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups. The person evaluating the patients will also not know about the assignment. Therefore, this study will be a double-blinded one. 2-3 Urological services with urine virtual stone. Intervention 1: The first intervention group will receive 15-15.5 mg of Markain 0.5% in the intervertebral space L3-L4 for spinal anesthesia by injection. Intervention 2: The second intervention group will receive 1 mg of Pethidine in the L3-L4 intervertebral space for spinal anesthesia by injection. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Bahar Khodayar
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 Baharkhodayar@yahoo.com Kermanshah University of Medical Sciences scientific Dr. Javad Amini Saman
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 Aminisamanj99@Gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for TUL surgery by their doctor Patients who are in ASA class 1 and 2 no limit no limit Both Patients with chronic diseases including heart disease and hypertension and advanced lung and neurological diseases Patients taking opium Patients who are contraindications to the spinal procedure N21 Calculus of lower urinary tract Treatment - Drugs Treatment - Drugs The first intervention group will receive 15-15.5 mg of Markain 0.5% in the intervertebral space L3-L4 for spinal anesthesia by injection. The second intervention group will receive 1 mg of Pethidine in the L3-L4 intervertebral space for spinal anesthesia by injection. Blood pressure changes. Timepoint: Every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery and in the recovery room every 15 minutes until the recovery criteria are met. Method of measurement: Using a pressure gauge. Heart rate changes. Timepoint: Every 5 minutes until the end of the first 30 minutes, then every 15 minutes until the end of surgery and in the recovery room every 15 minutes until the recovery criteria are met. Method of measurement: Using a pulse oximeter. Urinary retention. Timepoint: Before and after anesthesia. Method of measurement: Based on questions from the patient and based on observation and clinical examination. Kermanshah University of Medical Sciences Approved 2021-02-16 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)