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IRCT20141209020258N115 IRCT 2019-07-07 Arak University of Medical Sciences Comparing the effect of Dexmedetomidine and Fentanyl in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture Comparison of Dexmedetomidine and Fentanyl effect in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture 2019-04-21 anticipated 64 Complete https://irct.ir/trial/39983 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B .‏ In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.‏, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. 2-3 Femure fracture. Intervention 1: Intervention group1: We inject 5 microgram Dexmedetomidine plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America). Intervention 2: Intervention group2: We inject 20 microgram Fentanyl plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America). Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Kamali How to obtain: They have to write letters to the professors and the university Comments:
public Dr Shirin Pazuki
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 pazuki@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) ASA class 1 and 2 Patients undergoing femoral orthopedic surgery Lack of failure to perform spinal anesthesia No history of taking beta-blockers and alpha-2 calcium channel blockers and blockers Lack of cardiovascular problems No pregnancy Absence of coagulation disorders Non-localized infection in the spinal cord Absence of mental and psychological problems Lack of peripheral and central neuropathy 18 years 60 years Both Patient dissatisfaction Blocks failed Surgical operations more than 120 minutes Patients who have heart-respiratory arrhythmia during operation S72.0 Fracture of neck of femur Treatment - Drugs Treatment - Drugs Intervention group1: We inject 5 microgram Dexmedetomidine plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America). Intervention group2: We inject 20 microgram Fentanyl plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America). Mean arterial blood pressure. Timepoint: In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90. Method of measurement: Barometer. Heart rate. Timepoint: In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90. Method of measurement: Count. Percent of oxygen saturation. Timepoint: In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90. Method of measurement: Pulse oximetry. Duration of motor block. Timepoint: Every 5 minute. Method of measurement: Minute. Duration of Sensory block. Timepoint: Every 5 minutes. Method of measurement: Minute. Pain. Timepoint: At recovery and 2 and 4 and 8 postoperative. Method of measurement: Visual Analogue Scale Questionnaire. Mean of narcotic. Timepoint: 24 hour after surgery. Method of measurement: Milligram. Arak University of Medical Sciences Approved 2019-04-07 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)