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IRCT20200502047269N1 IRCT 2020-11-26 Iran University of Medical Sciences Comparison of the sedative effect of Remifentanil and Dexmidetomidine Comparison of the sedative effect of Remifentanil and Dexmidetomidine in patients undergoing venous arterial fistula implantation 2020-05-21 anticipated 32 Complete https://irct.ir/trial/47634 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups by permuted block randomization. The size of the blocks will randomly include 4 and 6 blocks, in each block, two and three participants will be equally placed in each of the intervention and control groups, respectively. One group receiving dexamidomethidine (bolus dose of 0.5 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min) or remifentanil (bolus dose of 0.5 μg / kg) Intravenously for 10 minutes at a maintenance dose of 0.5 to 0.25 μg / kg / min, Blinding description: Both patients and anesthesiologists will be completely unaware of the nature of prescription vials. For this purpose, vials will be covered with foil. Patients will be informed that they are participating in a research study but are not aware of the type of group assigned. 3 Patients undergoing venous arterial fistula implantation. Intervention 1: Intervention group 1: Dexamidomethidine administration (bolus dose of 0.4 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company. Intervention 2: Intervention group 2: Remifentanil administration (bolus dose of 0.5 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 0.25 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Use the resulting information by referring to it Where to obtain: Dr. Alireza Maleki, Firoozgar Hospital, Beh Afarin St., Karim Khan St., Valiasr Sq., Tehran- Dr.alireza_maleki@irimed.org How to obtain: Submit your request via email to Dr.alireza_maleki@irimed.org. Your reply will be given within three days. Comments:
public Alireza Maleki
Firoozgar Hospital, Beh Afarin St., Karim Khan St., Valiasr Sq., Tehran
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 2264 1112 dr.alireza_maleki@irimed.org Iran University of Medical Sciences scientific Alireza Maleki
Firoozgar Hospital, Beh Afarin St., Karim Khan St., Valiasr Sq., Tehran
Tehran Iran (Islamic Republic of) ۱۵۹۳۷۴۷۸۱۱ +98 21 2264 1112 dr.alireza_maleki@irimed.org Iran University of Medical Sciences Iran (Islamic Republic of) Age group 19 to 60 years Patients with stable hemodynamic status 19 years 60 years Both Patients with a history of cardiovascular abnormalities Patients with a history of chronic diseases such as liver disease Patients with a history of allergies to anesthetics, including opioids Patients with a history of opium use Pregnant or lactating women Recent respiratory tract infection Severe bronchopulmonary disease Treatment - Drugs Treatment - Drugs Intervention group 1: Dexamidomethidine administration (bolus dose of 0.4 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 1.00 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company. Intervention group 2: Remifentanil administration (bolus dose of 0.5 μg / kg intravenously over 10 minutes and maintenance dose of 0.5 to 0.25 μg / kg / min). Its manufacturer is Exir Pharmaceutical Company. Pain score. Timepoint: At the moment after the operation and also every half an hour, up to two hours after the operation. Method of measurement: Use of Visual Analogue Scale (VAS) scoring system. Nausea and vomiting. Timepoint: After surgery. Method of measurement: Observation. Hypertension. Timepoint: After surgery. Method of measurement: Mercury barometer. Oxygen saturation. Timepoint: After surgery. Method of measurement: Pulse oximetry. Tachycardia and bradycardia. Timepoint: After surgery. Method of measurement: Monitoring. Iran University of Medical Sciences Approved 2020-05-10 Ethics committee of Iran University of Medical Sciences Firoozgar Hospital, Beh Afarin St., Karim Khan St., Valiasr Sq., Tehran Tehran Tehran Iran (Islamic Republic of)