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IRCT20201207049639N8 IRCT 2022-03-31 Oroumia University of Medical Sciences Effect of norepinephrine with phenylephrine in the prevention of hypotension undergoing spinal anesthesia Comparison of norepinephrine with phenylephrine in the prevention and treatment of hypotension in cesarean section undergoing spinal anesthesia 2022-04-21 anticipated 40 Complete https://irct.ir/trial/62541 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 10 blocks (Totally 40 patients). Then, within each block, subjects will be randomly assigned to norepinephrine or phenylephrine group . Random assignment will be done using a random number table, Blinding description: Patients were unaware of their allocation into the intervention groups and the statistical analyzer received the data as codes, not the actual grouping. Patients remain unaware of being in intervention groups because after spinal anesthesia patients are prescribed sedatives and drugs are administered intra serum and the patient is unable to distinguish the type of drug because both are stored in brown glass. The statistical analyzer also received the data in codes A and B, not the norepinephrine and phenylephrine groups. 3 Hypotension. Intervention 1: Intervention group 1: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company)is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 50 micrograms of phenylephrine (Produced by Caspian company) will be injected intravenously. Intervention 2: Intervention group 2: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company) is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 5 micrograms of norepinephrine(Produced by Caspian company) will be injected intravenously . 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 There is no further information
public Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Hadi Hooshyar
Shahid Motahhari Hospital; Kashani street; Urmia; Iran.
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3198 8293 hooshyar.h@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Satisfaction to participate in the study Age between 20 to 45 years Lack of sensitivity to norepinephrine and phenylephrine 20 years 45 years Female Having liver, kidney and heart disease Sensitivity to anesthetics I95 Hypotension Treatment - Drugs Treatment - Drugs Intervention group 1: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company)is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 50 micrograms of phenylephrine (Produced by Caspian company) will be injected intravenously. Intervention group 2: In all patients, 10 mg (2 cc) of bupivacaine 0.5% (Produced by Caspian company) is injected intrathecally, and after the patient is in a supine position, systolic and diastolic blood pressure are measured and recorded every 5 minutes. In cases where the systolic blood pressure drops more than 20% of the initial value, 5 micrograms of norepinephrine(Produced by Caspian company) will be injected intravenously . Systolic blood pressure. Timepoint: Before intervention, 5, 10, 15, 20, 25 and 30 minutes after intervention. Method of measurement: Blood pressure monitor. Diastolic blood pressure. Timepoint: Before intervention, 5, 10, 15, 20, 25 and 30 minutes after intervention. Method of measurement: Blood pressure monitor. Nausea and vomiting. Timepoint: It is recorded up to 30 minutes after the intervention if observed. Method of measurement: Observation. Oroumia University of Medical Sciences Approved 2021-12-01 Ethics Committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Resalat Street, Jahad Ave., Urmia, Iran Urmia West Azarbaijan Iran (Islamic Republic of)