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IRCT20130311012782N41 IRCT 2020-03-03 Esfahan University of Medical Sciences Comparison of the effect of adding dexmedetomidine or fentanyl to ropivacaine on sensory and motor characteristics and analgesia after orthopedic lower limb surgery Comparison of Dexmedetomidine and Fentanyl as Adjuvant to intrathecal Ropivacaine in Lower Limb Orthopedic Procedures 2020-04-02 anticipated 90 Complete https://irct.ir/trial/45093 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, 90 patients undergoing lower limb orthopedic surgery were randomly divided into three groups of 30 each. Random allocation of patients between the three groups is done using random allocation software. At first the total sample size is entered into the software and then the number of study groups is entered. In software output, numbers 1 to 90 are randomly presented in three separate columns, according to which patients are divided into three groups according to the time of inclusion and as listed above to reach the required number in each group, Blinding description: The study was conducted in a double-blind manner and patients and researchers were uninformed with the type of drug administered. The drugs are drawn and coded on a similar syringe by an operating room staff member who is not involved in the study and provided to the plan administrator for injection. 3 Sensory and motor nerve blocks. Intervention 1: Intervention group: injection of 4.5 ml ropivacaine% isobaric + 5 micg dexmedetomidine in 5 ml normal slain. Intervention 2: Intervention group: Injection of 4.5 ml of isobaric ropivacaine 3% + 25 mg fentanyl in 5 ml normal slain. Intervention 3: Intervention group: Injection of 4.5 ml isobaric ropivacaine 3% in 5 ml normal normal slain. No - There is not a plan to make this available Justification or reason for not sharing IPD is The plan is owned by the government agency and cannot be shared.
public Mohamadjavad Hoseini
Department of Anesthesiology, Alzahra hospital, Sofeh street
Isfahan Iran (Islamic Republic of) 8434193474 +98 31 3668 5555 mohammadjavadhosseini84@yahoo.com Esfahan University of Medical Sciences scientific Reyhanak Talakoub
Department of Anesthesiology, Alzahra hospital, Sofeh street
Isfahan Iran (Islamic Republic of) 8434193474 0098 316685555 talakoub@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Weight less than 100 kg Patient undergoing lower extremity orthopedic surgery 18 years 65 years Both Pregnancy History of addiction or smoking, drugs and alcohol liver disease cardiovascular disease Chronic pain report lasting more than 6 months Drug sensitivity or ropivacaine, fentanyl and dexmedetomidine contraindication of spinal anesthesia Long-term drug history or opioid and NSAIDs Prevention Prevention Prevention Intervention group: injection of 4.5 ml ropivacaine% isobaric + 5 micg dexmedetomidine in 5 ml normal slain Intervention group: Injection of 4.5 ml of isobaric ropivacaine 3% + 25 mg fentanyl in 5 ml normal slain Intervention group: Injection of 4.5 ml isobaric ropivacaine 3% in 5 ml normal normal slain Time to start sensory block. Timepoint: After the intrathecal injection of the anesthetic drug. Method of measurement: Sensory testing with no sensation of tingling with Nidel No. 23 is evaluated as subcutaneous stimulation. Blood pressure. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: Pulse Oximeter. Heart rate. Timepoint: Every 15 minutes during surgery and recovery. Method of measurement: Pulse Oximeter. Postoperative pain. Timepoint: Every 15 minutes in recovery and every 2 hour in ward. Method of measurement: With using visual Analog Scale. The criterion is a line between zero to ten and zero in the sense of no pain and ten being the most severe equivalent of the pain experienced by the patient. With this concept, the patient is asked to indicate their current pain intensity on line. Esfahan University of Medical Sciences Approved 2020-01-19 Ethics committee of Isfahan University of Medical Sciences Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)