Comparison the effect of single dose medication in decreasing urgent ureteroscopy complications, a double blind randomized clinical trial

Effect of prescription of drugs on acute complications of Transurethral Lithotripsy

In this parallel clinical trial, block randomization is performed using an online program. In phase 3, 3 medications and a placebo are used to assess the efficacy of different medications in decreasing transurethral lithotripsy complications in 400 patients.

In this study, at Sina Hospital in Tehran, patients who are candidates for transurethral lithotripsy are randomly and blindly divided into four groups, and with three drugs in three groups and in group four without drugs, the prevalence of intervention complications is assessed.

Inclusion criteria: TUL candidate patients Exclusion criteria: Previous ureteral manipulation Having a DJ (Double J) or ureteral catheter Creatinine above 1.5 mg / dL Age over 65 years Weight less than 50 kg Contraindications or allergies to prescribed drugs Patients who are taking one of the above three drugs for any reason before seeking TUL. Patient dissatisfaction with participating in the research project

Four drug groups (tamsulosin, serum normal saline, ketorolac, and hyoscine) The first group received only one liter of normal saline (placebo) before TUL. The second group received tamsulosin capsules two nights before surgery. The third group received ketorolac before TUL with one liter of normal saline at least one hour before surgery. The fourth group received an ampoule of hyoscine with one liter of normal saline at least one hour before TUL.

Bladder injury, Ureterovesical junction injury, ureteral mucosa elevation, ureteral perforation, inability to reach the ureteral stone, inability to enter the ureter, ureteral avulsion, and need for a narrower ureteroscope

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.

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.

All data will be provided to the Vice-Chancellor for Research of Tehran University of Medical Sciences as a dissertation

6 months after the publication of the article

Scientific institutes and researchers

To share experiences and increase citations

To the e-mail address of Dr. Hamed Akhvizadegan (h-akhavizadegan@tums.ac.ir)

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.

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.