]>
IRCT20220612055143N1 IRCT 2022-06-18 Oroumia University of Medical Sciences Evaluation the effect of different dosages of prophylactic phenylephrine infusion effect on hypotension during surgery Comparing the different dosages of prophylactic phenylephrine infusion effect on hypotension in elderly patients under spinal anesthesia in orthopedic surgeries 2022-06-22 anticipated 60 Complete https://irct.ir/trial/64126 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 phenylephrine 10mg / ml in 100 ml of normal saline(group A) and phenylephrine 10mg / ml in 200 ml of normal saline (group B) 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. phenylephrine 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: Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 100 ml of normal saline immediately after changing position to supine position. Intervention 2: Intervention group:Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 200 ml of normal saline immediately after changing position to supine position. 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 Mitra Golmohammadi
Orjanse alley, Resalat blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 mitragolmohammadi@yahoo.com Oroumia University of Medical Sciences scientific Mitra Golmohammadi
Orjanse Alley, Resalat Blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 mitragolmohammadi@yahoo.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age over 60 years American Society of Anesthesiologists physical status classification I and II Patients under spinal anesthesia 60 years no limit Both Heart rate less than 45 Drug sensitivity to local anesthetics Existence of uncontrolled systemic diseases such as diabetes or high blood pressure Heart disease such as heart failure or arrhythmias History of neurological or psychological diseases Existence of any contraindications to performing spinal anesthesia I95.2 Hypotension due to drugs Prevention Prevention Intervention group: Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 100 ml of normal saline immediately after changing position to supine position. Intervention group:Phenylephrine, manufactured by BB Pharma, will be injected intravenously in 10 cc syringes containing 10 mg / ml in 200 ml of normal saline immediately after changing position to supine position. Mean blood pressure. Timepoint: In the first 10 minutes every minute and then every 5 minutes until the end of the operation. Method of measurement: None invasive blood pressure. Mean Pulse rate. Timepoint: In the first 10 minutes every minute and then every 5 minutes until the end of the operation. Method of measurement: Electrocardiogram. Nausea and vomiting. Timepoint: During operation. Method of measurement: patient observation. Oroumia University of Medical Sciences Approved 2022-05-28 Ethics commitee of Urmia University of Medical Sciences Orjanse alley, Resalat blvd Urmia West Azarbaijan Iran (Islamic Republic of)