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IRCT20190325043107N15 IRCT 2019-12-22 Tabriz University of Medical Sciences Ephedrine infusion during spinal anesthesia Effect of ephedrine infusion on hemodynamic changes in the elderly undergoing spinal anesthesia 2020-01-20 anticipated 100 Complete https://irct.ir/trial/41619 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The dice throw method will be used for randomization. The even number represents the individual in the intervention group and the odd number represents the individual in the control group, Blinding description: All participants will be given drug infusions or placebo (normal saline serum) in case of hypotension. The drug or placebo will be 50mm inside the syringe. The syringes are quite similar and their contents are colorless. The participant is unaware of the type of drug received and will be blind during the study. 3 Blood pressure. Intervention 1: Intervention group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, the infusion of ephedrine in the 50-mm syringe will begin at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the drug will be infused. The dose will be 60 mg per hour. The drug will be purchased from Iran Daroo Company . Intervention 2: Control group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, placebo infusion will begin in a 50-mm syringe at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the placebo will be infused. In our study, placebo is a normal saline serum that will be purchased from Iran Daroo Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Parichehr Mazoji
Iman Reza Hospital, Golgash Ave
East Azarbaijan Iran (Islamic Republic of) 5981764863 +98 41 3336 9586 parimaz@gmail.com Tabriz University of Medical Sciences scientific Parichehr Mazoji
Imam Reza Hospital, Golgasht Ave
Tabriz Iran (Islamic Republic of) 5981764863 +98 41 3334 7054 Parimaz@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Minimum age 65 years Candidate for spinal anesthesia 65 years no limit Both Cardiovascular diseases Diabetes Mellitus R03.0 Elevated blood-pressure reading, without diagnosis of hypertension Treatment - Drugs Placebo Intervention group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, the infusion of ephedrine in the 50-mm syringe will begin at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the drug will be infused. The dose will be 60 mg per hour. The drug will be purchased from Iran Daroo Company . Control group: Participants in this group will be randomly assigned to spinal anesthesia after random assignment. In the first ten minutes, blood pressure will be measured every 1 minute and then every three minutes. If blood pressure drops below 20%, placebo infusion will begin in a 50-mm syringe at a rate of three milliliters per hour and will continue until the blood pressure returns to normal. During surgery, if the blood pressure drops more than 20%, the placebo will be infused. In our study, placebo is a normal saline serum that will be purchased from Iran Daroo Company. Blood pressure. Timepoint: After spinal anesthesia, the patient's blood pressure will be measured every three minutes. Method of measurement: Barometer. Tabriz University of Medical Sciences Approved 2019-10-04 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)