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IRCT20100102002963N34 IRCT 2022-01-23 Yazd University of Medical Sciences The evaluation of the effect of administration of dexamethasone on hemodynamic variables and hypotension due to regional anesthesia in the women undergoing cesarean section The evaluation of the effect of intravenous dexamethasone on hemodynamic variables and post-spinal hypotension in the women undergoing cesarean section 2022-04-04 anticipated 60 Complete https://irct.ir/trial/59733 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly allocate 60 eligible applicants, we randomly divide them into two groups of 30 people. For this purpose, we use Random allocation software version 1.0 under Windows to create a sequence, and by using this software we make A list which is specified from 1 to 60 with group A or B treatment By Using this list, we give the first person who is eligible to enter the study, number one and the last person the number 60, then based on the random allocation list and by the software, it is determined which group A or B each person is in. Each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results, Blinding description: Patients and researchers themselves are unaware of which medication the patient has received, in this way, each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third person who is not involved in evaluating patients and recording results. 2 Hemodynamic variables and hypotension after spinal anesthesia in the women undergoing cesarean section. Intervention 1: Intervention group: In this group, dexamethasone at a dose of eight mg equivalent to 2 ml is injected slow intravenously and once immediately before spinal anesthesia to eligible patients. Intervention 2: Control group: In this group, 2 ml normal saline is injected slow intravenously and once immediately before spinal anesthesia to eligible patients. 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 I haven't decided yet. Its subscription schedule is not yet known
public Dr Shekoufeh Behdad
Central building of Yazd University of Medical Sciences, Bahonar Square
Yazd Iran (Islamic Republic of) 8915887857 0098 35 8231932 drbehdad@ssu.ac.ir Yazd University of Medical Sciences scientific Dr Shekoufeh Behdad
آدرس خیابان Central building of Yazd University of Medical Sciences, Bahonar Square
Yazd Iran (Islamic Republic of) 8915887857 +98 35 3823 1932 drbehdad@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) 20-35 years old women with term pregnancy American Society of Anesthesia (ASA) physical status I non- emergency repeated cesarean delivery spinal anesthesia 20 years 35 years Female BMI>35 chronic hypertension placenta previa placenta acreta gestational age <28 weeks Polyhydramnios I95.81 Postprocedural hypotension Treatment - Drugs Treatment - Drugs Intervention group: In this group, dexamethasone at a dose of eight mg equivalent to 2 ml is injected slow intravenously and once immediately before spinal anesthesia to eligible patients. Control group: In this group, 2 ml normal saline is injected slow intravenously and once immediately before spinal anesthesia to eligible patients. Systolic blood pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Diastolic Blood Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Mean Arterial Pressure. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Heart Rate. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Drop in systolic blood pressure below 90 mm Hg. Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Bradycardia(drop in heart rate below 50/ min). Timepoint: Before the injection of the study drug, immediately after the spinal anesthesia and then every three minutes until the birth of the baby and then every 5 minutes until the end of surgery, and every 15 minutes during recovery. Method of measurement: Using monitoring device. Hyperglycemia( blood glucose more than 200mg/dl). Timepoint: In the recovery (one hour after operation). Method of measurement: using Glucometer. Yazd University of Medical Sciences Approved 2021-10-27 Ethics Committee of Medical School - Shahid Sadoughi University of Medical Sciences, Yazd Faculty of Medicine. Shohadayegomnam Blv.Yazd Yazd Yazd Iran (Islamic Republic of)