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IRCT20151201025321N1 IRCT 2019-09-07 Islamic Azad University Induced hypotension in rhinoplasty Comparing sublingual nitroglycerine vs. combination of sublingual nitroglycerine and intravenous neostigmine on inducing hypotension on patients undergoing rhinoplasty in bouali hospital of Tehran 2019 2018-12-22 anticipated 60 Complete https://irct.ir/trial/41007 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: First, we designed a 10*6 table of random numbers including numbers from 01 to 60. The researcher will give each patient a number from the top of the list, the next patient will receive the bottom number and so on. patients with even numbers will receive A intervention and patients with odd numbers will receive B intervention, Blinding description: Patients don't know which drug is used for them. The surgeon who surveys the consequence of using the drug doesn't know which drug is used for the patient. Data analyzer don't know which drug is used for the patient. Researcher don't know which drug is used for the patient. 3 Condition 1: Induced hypotension. Condition 2: Rhinoplasty. Intervention 1: Intervention group: This group receives 0.3 mg/kg IV Neostigmine( researcher is blinded). Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol. Intervention 2: Control group: This group receives 0.3 mg/kg of IV placebo. Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Amirnezam Mir
Unit 12, NO 28, W. Kavian, Haghani highway
Tehran Iran (Islamic Republic of) 1541737175 +98 21 2285 2716 miramirnezam@gmail.com Islamic Azad University scientific Mahnaz Narimani Zamanabadi
ِDamavand street, Bouali Hospital, Anesthesiology Clinic
Tehran Iran (Islamic Republic of) 17117 +98 21 3334 8036 mahnaznarimani@yahoo.com Islamic Azad University Iran (Islamic Republic of) elective rhinoplasty ASA class I & II No addiction age between 15 to 60 15 years 60 years Both patient not pleased to participate in study drug reaction history ASA class III or more Addiction I95.2 Z41.1 Hypotension due to drugs Encounter for cosmetic surgery - rhinoplasty Prevention Placebo Intervention group: This group receives 0.3 mg/kg IV Neostigmine( researcher is blinded). Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol. Control group: This group receives 0.3 mg/kg of IV placebo. Inducing anesthesia is by 3 ug/kg Fentanyl,0.1-0.2 mg/kg Midazolam, 5 mg/kg Nesdonal and 0.5 mg/kg Atricirium. Maintaining anesthesia is by infusion of 1 ug/kg Fentanyl, 0.1 mg/kg Atracirium and 6-12 mg/kg/h Propofol. Blood pressure. Timepoint: Every 5 minute in first hour and every 15 minute in next hours. Method of measurement: Sphygmomanometer. Heart rate. Timepoint: ٍٍٍٍEvery 5 minute in first hour and every 15 minute in next hours. Method of measurement: Cardiac monitoring screen. Operation duration. Timepoint: At the end of the operation. Method of measurement: Digital chronometer. Islamic Azad University Approved 2019-03-04 Tehran Islamic Azad University Of Medical Sciences 12 Unit, NO 28, W. Kavian, Haghani highway Tehran Tehran Iran (Islamic Republic of)