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IRCT20080921001264N13 IRCT 2023-01-31 Gorgan University of Medical Sciences The effect of bolus injection of phenylephrine and norepinephrine in preventing hypotension after spinal anesthesia in patients undergoing elective cesarean elective. Comparison of bolus norepinephrine and phenylephrine for prophylaxis against post spinal anesthesia hypotension during elective caesarean delivery: A randomized controlled trial 2022-04-21 anticipated 90 Complete https://irct.ir/trial/67610 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research, Other design features: The study is designed in a random manner and after approval by the ethics committee of the university and registration in the clinical studies system of Iran, the consent form is fully explained to all pregnant women who are part of the study criteria. By meeting the existing conditions and understanding the informed consent, consent to conduct the study is obtained from them. 2 Complications of anesthesia during the puerperium. Intervention 1: Intervention group: NE norepinephrine group: 45 people: these people receive NE with a dose of 5 micrograms. Intervention 2: Control group: Phenylephrine PE group: 45 people: these people receive PE at a dose of 50 micrograms. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Our data will be available only to researchers working in academic and scientific institutions, and also people who work in industry can apply to receive them. Conditions: To promote science Where to obtain: Dr. Saideh Yazdanpanah sepideh.yp.md@gmail.com Dr. Sima Basharat sbesharatgp@gmail.com Dr. Erazberdi Ghourchaei arazberdi@gmail.com How to obtain: After sending an e-mail and a comprehensive explanation about the reason for using the data files, and after consulting with the rest of the project members, the data will be provided within 15 days. Comments:
public Dr. Erazbardi Ghorchaei
3rd floor- Martyr Khemet Dr. Abdullah Abbasi Heart Superspeciality Center-Martyr Sayad Shirazi Hospital-Gorgan
Gorgan Iran (Islamic Republic of) 4917867439 +98 17 3245 1660 ghourchaeiarazberdi@gmail.com Gorgan University of Medical Sciences scientific Dr. Sima Basharat
3rd floor- Shahid Dr. Abdullah Abbasi Heart Superspeciality Center- Shahid Sayad Shirazi Hospital- Gorgan
Gorgan Iran (Islamic Republic of) 4917867439 +98 17 3225 1910 sbesharatgp@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) The participants in this study include pregnant women, 36 to 41 weeks, between 18 and 45 years old, who referred to Sayad Shirazi Hospital in Gorgan. These patients are candidates for elective Cesarean elective Do not have any restrictions for spinal anesthesia such as patient's lack of consent, sensitivity to anesthesia, injection site infection, and high intracerebral pressure. Patients who enter the study in case of failure of spinal anesthesia, unpredictable complications during surgery, such as bleeding during surgery more than normal for a cesarean section without problems (more than 1500 ml) and the sensory level of T4 is higher than are excluded from the study. 18 years 45 years Female At the beginning of the study, patients with uncontrolled heart complications, high blood pressure disorders in pregnancy, diabetes, psychiatric and renal problems, systolic blood pressure less than 90 mm Hg, peripheral bleeding, coagulation disorders O89 Complications of anesthesia during the puerperium Treatment - Drugs Treatment - Drugs Intervention group: NE norepinephrine group: 45 people: these people receive NE with a dose of 5 micrograms. Control group: Phenylephrine PE group: 45 people: these people receive PE at a dose of 50 micrograms. In the first few minutes after the injection of both drugs, we expect an increase in blood pressure, and we also expect to maintain the heart rate after the use of norepinephrine. Timepoint: It was monitored every 2 minutes to 6 minutes, every 3 minutes to 15 minutes and every 5 minutes until the end of the surgery. Method of measurement: An increase in blood pressure was calculated as an increase in systolic pressure greater than 120% of baseline and a drop in blood pressure was calculated based on a decrease in systolic blood pressure below 80% of baseline. Due to the short half-life of the drug, which is up to 3 minutes, and its metabolite is also inactive, we do not expect secondary effects. Timepoint: 5 minutes later. Method of measurement: In this study, an increase in blood pressure is calculated as an increase in systolic pressure more than 120% of the baseline, and a drop in blood pressure is calculated based on a decrease in systolic blood pressure below 80% of the baseline. Gorgan University of Medical Sciences Approved 2021-11-14 Ethics committee in biomedical research of the Gorgan University of Medical Sciences 3rd floor- Shahid Dr. Abdullah Abbasi Heart Superspeciality Center- Shahid Sayad Shirazi Hospital- Gorgan Gorgan Golestan Iran (Islamic Republic of)