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IRCT20171014036771N1 IRCT 2019-01-16 Kashan University of Medical Sciences effect of intravenous and intratechal dexmedetomidine on shivering Comparison of efficacy of intravenous and intratechal dexmedetomidine on perioperative shivering after spinal anesthesia 2019-01-21 anticipated 150 Complete https://irct.ir/trial/36280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: in randomized blocking using 6 blocks are divided into three groups of intravenous dexmedetomidine, intrathecal and placebo, Blinding description: After explaining the entry into the study for patients and obtaining written consent from them and implementing the randomization method,Based on designated group, researcher or the person substituting the drug or placebo is prescribed, as in the intrathecal dexmedetomidine, IV normal saline is prescribes and in the group IV Dexmedetomidine, intrathecal normal saline is prescribes, and in the control group prescribes IV and intrathecal normal saline, Without the assessor being informed of the type of prescribing and patient group, and the unaware assessor who are anesthetist nurses in the operating and recovery room, record the variables of the study. 3 shivering after spinal anesthesia. Intervention 1: Intervention group: intrathecal Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 10µg/ml (5µg) and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour. Intervention 2: Intervention group: intravenous Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 1µg/ml first 1ml/kg/10min and then 0.5ml/kg/hour. Intervention 3: Control group: spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour. Yes - There is a plan to make this available What will be shared: data can be shared after unidentifiable people. When: Start the access period after printing the results. To whom: Researchers working in academic, scientific and industrial institutions. Conditions: Does not apply. Where to obtain: Dr. Hamed Pahlevani- kashan- shahid beheshti hospital-Postal code: 8715981151 pahlavani-h@kaums.ac.ir How to obtain: After sending the request by email or post, Immediately he is contacted and After knowing the cause and purpose of data access, They will be sent immediately via e-mail (or any other method). Comments:
public Hamed Pahlevani
Hekmat56 ave., Ghotb Ravandi blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 pahlavani-h@kaums.ac.ir Kashan University of Medical Sciences scientific Hamed Pahlevani
Hekmat 56 ave., Ghotb Ravandi blvd.
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 pahlavani-h@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 18-70 years/old ASA class I-II lower abdominal and lower limb surgery spinal anesthesia for surgery Duration of surgery is 30-120 minutes. 18 years 70 years Both Core body temperature higher than 37.5 ° C Pregnancy History of allergy to the drugs used in the study Contraindications for spinal anesthesia Patient with uncontrolled thyroid disease Parkinson's Disease disautonomy Raynaud syndrome Cardiopulmonary Disease History of alcohol consumption unstable coronary artery disease heart block (degree of II and III) congestive heart failure severe mitral stenosis vasodilator drugs consumption Surgeries requiring washing with excess fluid (eg TURP). Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: intrathecal Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 10µg/ml (5µg) and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour. Intervention group: intravenous Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 1µg/ml first 1ml/kg/10min and then 0.5ml/kg/hour. Control group: spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour. Shivering. Timepoint: During surgery every 5 minutes and during recovery every 15 minutes. Method of measurement: shivering Usta and Gozdemir scale. Core temperature. Timepoint: Every 15 minutes from the start of surgery to the end of recovery. Method of measurement: digital tympanic thermometer. Heart rate. Timepoint: The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes. Method of measurement: Digital Cardiac Monitoring. Systolic blood pressure. Timepoint: The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes. Method of measurement: Digital Cardiac Monitoring. Diastolic blood pressure. Timepoint: The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes. Method of measurement: Digital Cardiac Monitoring. Kashan University of Medical Sciences Approved 2016-08-28 Ethics committee of kashan University of Medical Sciences Hekmat 56 Ave., Ghotb Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)