]>
IRCT20200124046243N1 IRCT 2021-05-01 Esfahan University of Medical Sciences caudal block anesthesia in hypospadias repair Evaluation of the Impact of caudal block anesthesia on the postoperative complications of hypospadias repair in children 6 months to 15 years old: a randomized clinical trial 2021-04-21 anticipated 60 Complete https://irct.ir/trial/51788 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomized into two groups. Randomization will be performed by Random Allocation Software version 1.0.0. this software has been developed by M. Saghaei, MD, department of anesthesia, Isfahan University of Medical Science, Isfahan, Iran. (more about the software: https://pubmed.ncbi.nlm.nih.gov/15535880/). Blocks with an equal size of 6 will be used (View menu > Options > Equal size> 6). After every block, the number of participants in each group would be equal. ُThe researcher will contact the patients' parents and the patient will receive a closed envelope that contains the code based on the allocated group. The closed envelope will be given to the anesthesiologist in the operating room. The anesthesiologist will perform the anesthesia based on the code. Thus, the surgeon and the patients will not have information about the group allocation. (Download the software from here: https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html#Options), Blinding description: Double-blinding will be performed for the participants and the surgeon. The closed envelope will be given to the anesthesiologist in the operating room. The caudal block will be performed after the operation based on the code of the patients in the envelope and the surgeon and the patients will not have information about the group allocation. N/A hypospadias. Intervention 1: Intervention group: Caudal Epidural Block anesthesia plus general anesthesia. caudal anesthesia is performed, using small needle (24-27 G) by injecting 0.5 mg/Kg of 0.125% Marcaine. Induction of anesthesia is done with thiopental sodium (5 mg/kg), atracurium (0.6 mg/kg), fentanyl (2 microg/kg), and morphin (0.1 mg/kg).During surgery, anesthesia is continued with 1.25 % isofluran gas. Intervention 2: Control group: general anesthesia. 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 we should decide later with all co authors.
public saeid haghdani
Hezar Jarib
Isfahan Iran (Islamic Republic of) 1234567890 +98 31 3628 4662 saeed_haghdani@yahoo.com Esfahan University of Medical Sciences scientific Saeid Haghdani
Hasheminejad Kidney Research Center (HKRC), Iran University of Medical Science, Tehran, Iran
Tehran Iran (Islamic Republic of) 1234567890 +98 21 81161 saeed_haghdani@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) boys candidate for hypospadias repair age between 6 month and 15 years 6 months 15 years Male two stage hypospadias repair history of previous surgery history of spinal cord anomaly history of diabet history of other congenital defects history of bleeding diathesis history of drug allergy to bupivacaine not using anticoagulants or antiplatelets Q54 Hypospadias Treatment - Other Treatment - Other Intervention group: Caudal Epidural Block anesthesia plus general anesthesia. caudal anesthesia is performed, using small needle (24-27 G) by injecting 0.5 mg/Kg of 0.125% Marcaine. Induction of anesthesia is done with thiopental sodium (5 mg/kg), atracurium (0.6 mg/kg), fentanyl (2 microg/kg), and morphin (0.1 mg/kg).During surgery, anesthesia is continued with 1.25 % isofluran gas. Control group: general anesthesia Hypospadias surgery complications. Timepoint: 1st week, 1st Month and 6th month after surgery. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2019-05-19 Ethic committee of Isfahan university of Medical Science Hezar jarib Ave Isfahan Isfehan Iran (Islamic Republic of)