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IRCT20161221031505N1 IRCT 2022-06-25 Tehran University of Medical Sciences Assessing the efficacy of different medications in decreasing complications of transureteral lithotripsy Comparison the effect of single dose medication in decreasing urgent ureteroscopy complications, a double blind randomized clinical trial 2022-07-23 anticipated 400 Complete https://irct.ir/trial/63862 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization In this section using the site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) randomization is done with quadruple blocks (equal to the number of groups). The list of each of four patients is entered in a block, respectively. The first and second-year urology assistants who are responsible for preparing the patient in the urology ward will give the necessary dose to the patient and record it and then the patient is transported to the operating room without knowing about the medicine received, Blinding description: The medication is prescribed and registered by the first-year assistant in the ward without mentioning its name to the patient and the stone crushing is done by the third-year assistant in the operating room without knowing the medication. 3 Ureteral stone. Intervention 1: Intervention group number 1: 1 amp. Hyoscine 20 mg made by Exir company diluted in one liter normal saline is infused via vein catheter 1 hour before intervention. Intervention 2: Intervention group number 2: 1 amp. ketorolac 30 mg made by Exir company diluted in one liter normal saline is infused via vein catheter 1 hour before intervention. Intervention 3: Intervention group number 3: 2 caps. Tamsulosin made by Exir company is prescribed for the patient and tomorrow one liter normal saline is infused via vein catheter during one hour before surgery. Intervention 4: Control group or intervention 4: 1 liter normal saline is infused one hour before surgery. Yes - There is a plan to make this available What will be shared: All data will be provided to the Vice-Chancellor for Research of Tehran University of Medical Sciences as a dissertation When: 6 months after the publication of the article To whom: Scientific institutes and researchers Conditions: To share experiences and increase citations Where to obtain: To the e-mail address of Dr. Hamed Akhvizadegan (h-akhavizadegan@tums.ac.ir) How to obtain: Up to one month after the email and review of the application and then obtaining the license of the Vice Chancellor for Research, information will be provided to the person. Comments: In addition, because the research is a dissertation, a copy of it is available to the public in the Central Library as well as in the library of Sina Hospital.
public Hamed Akhavizadegan
Hasan Abad square, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1538 h-akhavizadegan@tums.ac.ir Tehran University of Medical Sciences scientific Hamed Akhavizadegan
Sina hospital, Hasan abad square
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1538 h-akhavizadegan@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Candidates of transureteral lithotripsy 18 years 65 years Both Renal dysfunction, Creatinine more than 1.5 mg/dl Previous ureteral intervention Having Double J or ureteral catheter age higher than 65 Weight less than 50 kg Contraindication or allergy to medications used in project History of using medications before intervention Patient does not want to participate in study N 21 Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group number 1: 1 amp. Hyoscine 20 mg made by Exir company diluted in one liter normal saline is infused via vein catheter 1 hour before intervention. Intervention group number 2: 1 amp. ketorolac 30 mg made by Exir company diluted in one liter normal saline is infused via vein catheter 1 hour before intervention. Intervention group number 3: 2 caps. Tamsulosin made by Exir company is prescribed for the patient and tomorrow one liter normal saline is infused via vein catheter during one hour before surgery. Control group or intervention 4: 1 liter normal saline is infused one hour before surgery. Reducing damage to the bladder. Timepoint: During TUL. Method of measurement: Observing procedure. Reducing damage to the ureteral entrance to the bladder. Timepoint: During TUL. Method of measurement: Observing procedure. Reducing ureteral mucosa injury. Timepoint: During transurethral lithotripsy. Method of measurement: Observing the procedure. Reducing ureteral perforation. Timepoint: During transurethral lithotripsy. Method of measurement: Observing the procedure. Reducing ureteral stone riching failure. Timepoint: During transurethral lithotripsy. Method of measurement: Observation the procedure. Reducing inability to enter the ureter. Timepoint: During transurethral lithotripsy. Method of measurement: Observation during procedure. Reducing ureteral avulsion. Timepoint: During transurethral lithotripsy. Method of measurement: Observing during procedure. Reducing the need for a narrower ureteroscope. Timepoint: During transurethral lithotripsy. Method of measurement: Observing during procedure. Tehran University of Medical Sciences Approved 2020-08-27 Ethical committee of Tehran University of Medical Sciences Sina hospital, Hasn Abad square, Tehran Tehran Iran (Islamic Republic of)