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IRCT20180602039954N1 IRCT 2019-03-10 Ahvaz University of Medical Sciences Comparsion of the effect of dexmedetomidine with morphine in surgeries under epidural anesthesia Comparsion of the effect of dexmedetomidine and bupivacaine with morphine and bupivacaine on block quality in leg fracture surgeries under epidural anesthesia 2018-01-21 anticipated 80 Complete https://irct.ir/trial/31662 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization with a random number table is that envelopes are prepared and printed by a member of the research team and random numbers with the help of the Randomaize.com site, and will be embedded in the envelope, and the person will sign the consent form if they wish. Remove an envelope and then open it and enter the intervention or control group based on the contents of the envelope, Blinding description: Patients, responsible for collecting data, data analyzer. 3 Leg fracture. Intervention 1: Intervention group1: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus dexmedetomidine 1µg/kg (B+D). Intervention 2: Intervention group2: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus morphine 2mg/kg (B+M). Yes - There is a plan to make this available What will be shared: Documentation of study, Documentation used in the study, Collected data files, Participants' data after unidentifiable person profile When: Access to documentation and data are possible at the end of 2019. To whom: Academic researchers, Anesthesiologists, Anesthetic technicians Conditions: Use in the process of treatment in the operating room and processes related to anesthesia Where to obtain: Deputy of Research and Technology, Jundishapur University of Medical sciences How to obtain: Applicant can access documentation by the written request at the end of 2019. Comments:
public Mohammad Reza Gooshe
Azadegan Ave,Imam Khomeini Hospital
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3311 Goosheh-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Fatemeh Moftakhar
No:9-Edalat building-West12th St-Kian abad
Ahvaz Iran (Islamic Republic of) 1579461357 +98 61 3338 3372 goosheh-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients aged 18-60 years old with anesthesia risk ASA I, II 18 years 60 years Both Lack of satisfaction with epidural blocking Patients dependent on any psychiatric drug Patients with localized infection at the site of the epidural block Patients who had an allergy to the study drugs. Patients with neurological and neuro-macular diseases and psychologists Patients with coagulation disorder Patients who require an analgesic drug during surgery. Patients who fail their epidural block and were under general anesthesia Pregnant women S82.8 Other fractures of lower leg Treatment - Other Treatment - Drugs Intervention group1: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus dexmedetomidine 1µg/kg (B+D). Intervention group2: consisted of patients who received 12 ml of 0.5% bupivacaine hydrochloride plus morphine 2mg/kg (B+M). Block Epidural Quality. Timepoint: Epidural block every two minutes until the sensory level reaches T12, then every 15 minutes; motion block every 5 minutes to bromage 3 times every 30 minutes; Sedation Score every 30 minutes; VAS Score every 30 minutes; Bp, HR; Sat O2 every 5 minutes to half an hour every 15 minutes. Method of measurement: Sensory block with cold swab; Motion block with Bromage scale; Postoperative pain using VAS score; Sedation using Ramsay Scale method. Ahvaz University of Medical Sciences Approved 2018-02-18 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences No 9-Edalat Building-West 12th ST-Kian Abad Ahvaz Khouzestan Iran (Islamic Republic of)