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IRCT20200725048206N1 IRCT 2020-08-20 Ilam University of Medical Sciences Evaluation of the effect of phenylephrine in cesarean section Evaluation of the comparative effect of hemodynamic changes due to prophylactic Prescription of phenylephrine in three forms: bolus, subcutaneous and infusion in mothers with selective cesarean section under spinal anesthesia with marcaine 2020-07-31 anticipated 120 Complete https://irct.ir/trial/49869 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After completing the baseline assessment, patients were divided into three intervention groups and one control group. Randomization was performed using the block method (with block size of 4 or 6 and allocation ratio of 1: 1). Block randomization is used to reduce bias and achieve equilibrium in allocating participants to the study groups. Random allocation concealment was performed using opaque sealed envelopes with random sequences. Random allocation sequence is done using a computer-generated Kendall and Smith random number table. These tables have random numbers in both row and column directions, usually up to 99 rows and columns, and row and column digits. The cells are placed in five-digit blocks next to each other and separately to facilitate its use. This step is performed by a statistician who is not part of the research team. The random allocation sequence was hidden in closed opaque envelopes so that participants were assigned to 4 groups, Blinding description: The anesthesiologist and other members of the treatment staff and participants in the study are informed but the researcher is not As follows: Participants will be notified upon consent According to the decision of the anesthesiologist, one of the intervention methods is selected and after the prescription, the researcher, who is not aware of the prescription method, starts recording the data. 3 Hemodynamics of pregnant women under spinal anesthesia. Intervention 1: Intervention group 1: Bolus method: For patients who are going to receive bolus prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 1.5 µ g / kg of phenylephrine is injected 1 to 2 minutes before anesthesia. If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 µg of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. Intervention 2: Intervention group 2: Infusion method: For patients who are going to receive infusion prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 0.15 g / kg / min phenylephrine is injected intravenously for 30 minutes 1 to 2 minutes before anesthesia . If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 g of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. In the infusion group, the drug is discontinued if the systolic blood pressure increases by more than 20% of baseline. Intervention 3: Intervention group 3: subcutaneous: For patients who are supposed to receive subcutaneous prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 5 to 10 minutes before anesthesia, 5 mg of phenylephrine is injected into the deltoid site. In case of systolic blood pressure drop by 20% the base of systolic blood pressure is given alternately 50 µg of intravenous phenylephrine. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. Intervention 4: Control group: In patients in the control group who do not receive phenylephrine (Beacon Pharmaceuticals Ltd), in case of systolic blood pressure drop of less than 20% of baseline or less than 100 mm Hg, they receive µg/kg 1/5 of phenylephrine in bolus and STAT, and in case of drop again the dose is repeated. 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 will publish after complete the entire study
public Majid Aftabi
Tajarian Alley 1 , Tajarian St , Chalimar Town
Ilam Iran (Islamic Republic of) 6931134573 +98 84 3222 1999 majidaftabi73@gmail.com Ilam University of Medical Sciences scientific Majid Aftabi
Chalimar Town , Tajarian St , Tajarian 1 Alley
Ilam Iran (Islamic Republic of) 6931134573 +98 84 3222 1999 majidaftabi73@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Pregnant women Term Single pregnancy Elective cesarean section candidate 18 years 35 years Female History of hypertension (BP> 140/90 Diabetes Cardiovascular and cerebral disease Recognized fetal anomaly Any contraindication to spinal anesthesia Mothers who are at the beginning of the labor phase Prevention Prevention Prevention Diagnosis Intervention group 1: Bolus method: For patients who are going to receive bolus prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 1.5 µ g / kg of phenylephrine is injected 1 to 2 minutes before anesthesia. If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 µg of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. Intervention group 2: Infusion method: For patients who are going to receive infusion prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 0.15 g / kg / min phenylephrine is injected intravenously for 30 minutes 1 to 2 minutes before anesthesia . If systolic blood pressure drops by 20% of basal systolic blood pressure, 50 g of intravenous phenylephrine is given intermittently. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. In the infusion group, the drug is discontinued if the systolic blood pressure increases by more than 20% of baseline. Intervention group 3: subcutaneous: For patients who are supposed to receive subcutaneous prophylactic phenylephrine (Beacon Pharmaceuticals Ltd) , 5 to 10 minutes before anesthesia, 5 mg of phenylephrine is injected into the deltoid site. In case of systolic blood pressure drop by 20% the base of systolic blood pressure is given alternately 50 µg of intravenous phenylephrine. In cases where the heart rate is less than 50 beats per minute, atropine (Darou Pakhsh Co) 0.5 mg is prescribed. Control group: In patients in the control group who do not receive phenylephrine (Beacon Pharmaceuticals Ltd), in case of systolic blood pressure drop of less than 20% of baseline or less than 100 mm Hg, they receive µg/kg 1/5 of phenylephrine in bolus and STAT, and in case of drop again the dose is repeated Blood pressure. Timepoint: Base and minutes 5 and 15 and 30 and 60 and 90 and 120. Method of measurement: Cardiac monitor machine and blood pressure meter. Heart rate. Timepoint: Base and minutes 5 and 15 and 30 and 60 and 90 and 120. Method of measurement: Cardiac monitor machine and pulse oximeter. Apgar score. Timepoint: Minutes 1 and 5. Method of measurement: Physical examination. Umbilical cord blood Paco2 test. Timepoint: After birth. Method of measurement: Laboratory instruments. Umbilical cord blood HCO3 test. Timepoint: After birth. Method of measurement: Laboratory instruments. Umbilical cord blood pH test. Timepoint: After birth. Method of measurement: Laboratory instruments. Umbilical cord blood Base excess test. Timepoint: After birth. Method of measurement: Laboratory instruments. Ilam University of Medical Sciences Approved 2020-07-14 Ethics Committee of Ilam University of Medical Sciences Ilam University of Medical Sciences Campus , Banganjab, Research Blvd. , Ilam Ilam Ilam Iran (Islamic Republic of)