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IRCT20190131042569N4 IRCT 2020-08-23 Research Department of Shahid Beheshti University of Medical Sciences The effect of epidural infusion of Dexmedetomidine and Ropivacaine on erection following reconstructive urethral surgery Effectiveness comparison of epidural Dexmedetomidine vs Ropivacaine infusion to prevent erection following reconstructive urethral surgery 2020-08-10 anticipated 30 Complete https://irct.ir/trial/48304 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using computer generated simple randomization (random number generator software) to design two groups (dexmedetomidine vs ropivacaine), Blinding description: Due to the fact that patients in both groups have epidural catheters and do not know which drug is used, they are blind. The anesthesiologist in charge is not aware of the patient's group and drugs that is used in infusion pump . And the person responsible for follow-up and recordings data has no information about the patient's group and only the person responsible for preparing epidural infusion pump is aware of the patient's groups. 3 Erection. Intervention 1: Intervention group 1: At the end of operation, the continuous infusion pump with a total volume of 100 cc containing dexmedetomidine 50 micro grams and sterile water; 6 cc per hour is connected to the epidural catheter. Intervention 2: Intervention group 2: At the end of the operation, the continuous infusion pump with a total volume of 100 cc containing Ropivacaine 0.125% and sterile water; 6 cc per hour is connected to the epidural catheter. Yes - There is a plan to make this available What will be shared: Participant data (age, grade of erection and type of patient's group) are to be shared. When: 1 year after publication To whom: Researchers working in academic institutions Conditions: Using data and analysis for use in academic research Where to obtain: Send an Email to Dr.Nima Saeedi, Email Address: nimasaeedi7@yahoo.com How to obtain: Send request via Email and after 1 week will be replied. Comments:
public Nima Saeedi
No. 11, First East Ave., Bistochahar metri Ave., Tehran
Tehran Iran (Islamic Republic of) 1997778416 +98 21 2641 8939 nimasaeedi7@yahoo.com Shahid Beheshti University of Medical Sciences scientific Nima Saeedi
No. 11, First East Ave., Bistochahar metri Ave., Tehran
Tehran Iran (Islamic Republic of) 1997778416 +98 21 2641 8939 nimasaeedi7@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients between 20-60 years old candidate for reconstructive urethral surgery 20 years 60 years Male History of cardiac disease ( Syncope, Arrhythmia and bradycardia) History of allergic reaction to drug which is used in the study Prevention Prevention Intervention group 1: At the end of operation, the continuous infusion pump with a total volume of 100 cc containing dexmedetomidine 50 micro grams and sterile water; 6 cc per hour is connected to the epidural catheter. Intervention group 2: At the end of the operation, the continuous infusion pump with a total volume of 100 cc containing Ropivacaine 0.125% and sterile water; 6 cc per hour is connected to the epidural catheter. Erection after the reconstructive urethral surgery. Timepoint: Daily for one week. Method of measurement: Questionnaire (quality and degree of erection). Research Department of Shahid Beheshti University of Medical Sciences Approved 2020-08-09 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Science, Arabi Ave., Daneshjoo Blvd., Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)