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IRCT20160529028141N4 IRCT 2022-10-29 Iran University of Medical Sciences Comparison of the effect of Norepinephrin and Ephedrine in the treatment of hypotension due to spinal anesthesia in cesarean section on fetal umbilical cord PH Comparison of the effect of Norepinephrin and Ephedrine in the treatment of hypotension due to spinal anesthesia in cesarean section on fetal umbilical cord pH - A double-blinded randomized controlled trial 2022-10-23 anticipated 48 Complete https://irct.ir/trial/66080 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with different block sizes will be used to randomly assign two groups with 24 participants in each group (48 patients in total). The size of the blocks will be a multiple of 2 and a divisor of 48. Initially, the block sizes are chosen randomly. Then, for each block, different permutations are randomly determined by the Randomization Allocation Software. In each block, the number of patients in the groups is equal, and blinding is used to not reveal the permutations in the last patients of each block, Blinding description: This study is conducted in a double-blind manner. The patients will be blind to type of injected medicine. Only the anesthesiologist will be aware of patient allocation and will control the condition of the patients during anesthesia. Outcomes will be collected in checklists by one of the researchers who is not aware of the patients' allocation. 3 Hypotension induced by spinal anesthesia in cesarean section. Intervention 1: Intervention: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus norepinephrine will be injected. Intervention 2: Control: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus ephedrine will be injected. 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 Ali Mazouri
Hemmat express
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2293 9996 mazouri.a@iums.ac.ir Iran University of Medical Sciences scientific Ali Mazouri
Iran university of medical sciences - Hemmat express- Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2293 9996 mazouri.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Pregnant women Age 20 to 35 years Candidate for elective cesarean section Singleton pregnancy Gestational age 36 to 40 weeks 20 years 35 years Female History of hypertension (>140/90) History of cardiovascular or cerebrovascular diseases Gestational hypertension History of high-risk pregnancies (e.g. multiparity or intrauterine growth retardation) Abnormalities of the placenta and umbilical cord Contraindications to spinal anesthesia (patient refusal for spinal anesthesia, coagulopathies, infection in the anesthesia area, bleeding or hypovolemic shock) O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Drugs Treatment - Drugs Intervention: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus norepinephrine will be injected. Control: In case of hypotension induced by spinal anesthesia (drop in systolic blood pressure more than 20% of baseline), 10 milligram bolus ephedrine will be injected. Umbilical artery pH level. Timepoint: Immediately after delivery. Method of measurement: Biochemical tests. Umbilical artery lactate level. Timepoint: Immediately after delivery. Method of measurement: Biochemical tests. Iran University of Medical Sciences Approved 2022-08-06 Faculty of medicine - Iran university of medical sciences (Research Ethics Committee) Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran Tehran Tehran Iran (Islamic Republic of)