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IRCT20160430027677N21 IRCT 2022-02-28 Oroumia University of Medical Sciences Evaluation the effect of ephedrine on intraoperative blood pressure The effect of ephedrine and placebo on hemodynamic changes in patients undergoing percutaneous nephrolithotomy with spinal anesthesia 2022-04-04 anticipated 60 Complete https://irct.ir/trial/62169 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The number of patients in this study will be 60. This number of patients will be exclusive randomly assigned into two groups of ephedrine (group H) and placebo (group P) using Random Allocation Software 2.0, and the target codes will be written and placed in sealed envelopes with sequential allocation using double-blind method, Blinding description: The anesthesiologist will be unaware of which patient will be assigned to which group. Ephedrine and placebo syringes will be identical and only the operating room will knew about the contents of each of them, and finally, after collecting information from the anesthesia residents, the anesthesiologist will be informed of the group each patient will be assigned to. 2-3 blood pressure during surgery. Intervention 1: Intervention group: Ephedrine drug with the name of BB Pharma manufacturer in the form of 5 cc syringes containing 5 ml solutions diluted with water, 10 mg of ephedrine prepared per 1cc will be injected intravenously immediately after changing the lithotomy position to the supine position. The injection will be given once. Intervention 2: Control group: Placebo syringes are 5 cc syringes containing distilled water and immediately after changing the lithotomy position to the supine position, 1cc will be injected intravenously.The injection will be given once. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences scientific Shahryar Sane
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sanesh@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) aged 20 to 60 years American Society of Anesthesiologists physical status classification I and II Patients under spinal anesthesia Stones larger than 10 mm in lower calyx and large stones Impacted in proximal ureter 20 years 60 years Both Patients with pilocalis stones larger than 20 mm and Extracorporeal Shock Wave Lithotripsy resistant 10-20 mm stones patient with unmodified coagulopathy patient with untreated active urinary tract infection Patients with skeletal deformity Patients with a history of drug allergy patient with high volume bleeding and need for blood transfusion I95.2 Hypotension due to drugs Prevention Placebo Intervention group: Ephedrine drug with the name of BB Pharma manufacturer in the form of 5 cc syringes containing 5 ml solutions diluted with water, 10 mg of ephedrine prepared per 1cc will be injected intravenously immediately after changing the lithotomy position to the supine position. The injection will be given once. Control group: Placebo syringes are 5 cc syringes containing distilled water and immediately after changing the lithotomy position to the supine position, 1cc will be injected intravenously.The injection will be given once. Mean blood pressure. Timepoint: During operation every 3 minutes after drug injection. Method of measurement: None invasive blood pressure. Pulse rate. Timepoint: During operation every 3 minutes after drug injection. Method of measurement: Electrocardiogram. Nausea and vomiting. Timepoint: During operation. Method of measurement: patient observation. urmia University of Medical Sciences Approved 2021-09-14 research ethics commitees of islamic Azad university_ Tabriz Branch Pasdaran blvd, Islamic Azad university_ Tabriz Branch Tabriz East Azarbaijan Iran (Islamic Republic of)