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IRCT20120915010841N24 IRCT 2020-12-26 Hamedan University of Medical Sciences The effect of Norepinephrine on the prevention of post spinal hypotension Comparison of the effect of 5 and 10 μg bolus doses of intravenous norepinephrine on the prevention of hypotension after spinal anesthesia with 0.5% bupivacaine in cesarean section: a double-blind randomized clinical trial 2020-07-22 anticipated 126 Complete https://irct.ir/trial/52703 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, Block Randomization method is used as 6 blocks for randomization. In this way, we put 6 pieces of paper with the letter A and 6 pieces of paper with the letter B and 6 pieces of paper with the letter C in a bag and mix them, then for each patient that enters the study, one of the papers is taken out randomly and will be assigned to one of the three groups: A (norepinephrine 5 micrograms), B (norepinephrine 10 micrograms) and group C (normal saline), depending on whether the drawn sheet is either A , B or C. Then, for the next series of patients, the papers are returned to the bag and the same process is repeated until the end of the sample volume, Blinding description: Immediately after spinal anesthesia in group A, 5 micrograms of intravenous norepinephrine ( 1 ml), in group B, 10 micrograms of intravenous norepinephrine ( 1 ml) and in group C, 1 ml normal saline as a control group In similar syringes , which are pre-specified by the anesthesia nurse according to the list, are prepared and injected intravenously. 2-3 Spinal anesthesia in cesarean section. Intervention 1: Intervention group1: Immediately after spinal anesthesia in group A, 5 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. Intervention 2: Intervention group 2: Immediately after spinal anesthesia in group B, 10 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. Intervention 3: Control group: Immediately after spinal anesthesia in group C, one milliliter of normal saline is injected intravenously as a placebo. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. 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 Because the study is not finished yet.
public Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences scientific Nahid Manouchehrian
Fatemieh Hospital, Pasdaran Street
Hamadan Iran (Islamic Republic of) 6517789971 +98 81 3827 7012 manuchehriann@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in the project Pregnant women aged 18 to 46 and term pregnancy Candidate for cesarean section under spinal anesthesia 18 years 46 years Female Patients who have failed spinal anesthesia and undergo general anesthesia Lung disease, heart disease, fever, hypertension, diabetes and cardiac arrhythmia Emergency cesarean section due to meconium and fetal distress preeclampsia and eclampsia Multiple pregnancies Contraindications to spinal anesthesia (high ICP, hypovolemia, anemia, coagulation disorders, etc.) History of taking ergotamine Initial systolic pressure less than 90 mmHg Prevention Prevention Placebo Intervention group1: Immediately after spinal anesthesia in group A, 5 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. Intervention group 2: Immediately after spinal anesthesia in group B, 10 micrograms of intravenous norepinephrine (with a volume of one ml) of 0.1% norepinephrine ampoule made by Normon Spain (importer of Tadbir Kalay Jam) is injected intravenously. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. Control group: Immediately after spinal anesthesia in group C, one milliliter of normal saline is injected intravenously as a placebo. Then systolic, diastolic blood pressure, mean arterial pressure and heart rate of the patient at specific intervals are measured and recorded. Blood pressure. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, and every 10 minutes until the end of the surgery. Method of measurement: Automatic non-invasive blood pressure device. Heart Rate. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, and every 10 minutes until the end of the surgery. Method of measurement: pulse oximetry. Nausea and Vomiting. Timepoint: During and after surgery. Method of measurement: Observation. New born Apgar. Timepoint: 1&5 minutes after delivery. Method of measurement: Apgar Score. The amount of ephedrine have been consumed. Timepoint: During surgery. Method of measurement: mg. The amount of atropine have been consumed. Timepoint: During surgery. Method of measurement: mg. Hamedan University of Medical Sciences Approved 2020-07-11 Ethics Committee of Hamadan University of Medical Sciences Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)