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IRCT20201115049395N1 IRCT 2020-12-05 Karaj University of Medical Sciences Comparison of the effect and side effects of intravenous epinephrine and ephedrine in controlling hypotension and heart rate in cesarean section women Comparing the effect and complications of intravenous Epinephrine and Ephedrine in management of spinal anesthesia hypotension and bradycardia in elective caesarian section 2020-09-14 anticipated 126 Complete https://irct.ir/trial/52328 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples are entered into the study in an accessible manner and randomly assigned to the intervention and control groups using randomization software, Blinding description: The researcher and patient assessor who analyzed the data both used patient codes .Also, the titles of the groups were coded with A and B, but neither of them knew which of the two was the epinephrine group and the control group. 3 Hypotension and bradycardia following injection of spinal anesthesia. Intervention 1: Intervention group : Epinephrine is injected at a dose of 4 micrograms bolus until the mother reaches systolic blood pressure of more than 100 mm Hg. Intervention 2: control group :Intravenous ephedrine at a dose of 10 mg as a bolus until the mother reaches systolic blood pressure more than 100 mm Hg. Yes - There is a plan to make this available What will be shared: The study protocol and informed consent form and clinical study report and part of the participants' data file are shared as the main outcome. When: 2 months after printing the results To whom: All Conditions: No conditions are required. Where to obtain: Fatemeh moradi - fatiiiim73@gmail.com How to obtain: Information will be available within 2 weeks after sending email and authentication. Comments:
public Fatemeh moradi
unit6 , Western A3 block , Imam Reza Complex , Shohada Ave. , Gheibi st. , Javanmard ghasab , Tehran
Tehran Iran (Islamic Republic of) 1845943897 +98 21 3680 1995 fatiiiim73@gmail.com Karaj University of Medical Sciences scientific Fatemeh moradi
Unit6 , Western A3 block , Imam Reza Complex , Shohada Ave. , Gheibi st. , Javanmard ghasab , Tehran
Tehran Iran (Islamic Republic of) 1845943897 +98 21 3680 1995 fatiiiim73@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Pregnant women 40-20 years old in ASA2 class Gestational age 40-36 weeks A drop in blood pressure of more than 20% or a decrease in systolic blood pressure of less than 100 mm Hg 20 years 40 years Female Contraindications for spinal anesthesia Primary blood pressure more than 90/140 mm Hg or heart disease Diagnosed diseases of the placenta Sensitivity to the drugs used Treatment - Other Treatment - Other Intervention group : Epinephrine is injected at a dose of 4 micrograms bolus until the mother reaches systolic blood pressure of more than 100 mm Hg control group :Intravenous ephedrine at a dose of 10 mg as a bolus until the mother reaches systolic blood pressure more than 100 mm Hg The rate of hypotension. Timepoint: Before injecting spinal anesthesia then every 2 minutes to 20 minutes and then every 5 minutes to 45 minutes. Method of measurement: Measurement by monitoring device. Bradycardia. Timepoint: Before injecting spinal anesthesia then every 2 minutes to 20 minutes and then every 5 minutes to 45 minutes. Method of measurement: Measurement by monitoring device. Apgar fetus. Timepoint: 1 minute and 5 minutes after delivery. Method of measurement: Apgar scoring form of 10 points. Fetal pH. Timepoint: After delivery and umbilical cord incision. Method of measurement: By sending a cord blood sample to the laboratory and determining the pH of the fetus. Karaj University of Medical Sciences Approved 2020-11-14 Ethics committee of Alburz University of Medical Sciences kamali hospital , kamali st. , shahid beheshti Ave , city of karaj , alburz karaj Alborz Iran (Islamic Republic of)