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IRCT20201207049639N1 IRCT 2020-12-20 Oroumia University of Medical Sciences Evaluation of the Phenylephrine effect on hypotension in cesarean section Evaluation of the prophylactic infusion effect of Phenylephrine on hypotension in cesarean section under spinal anesthesia 2019-03-21 anticipated 100 Complete https://irct.ir/trial/52986 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into intervention and control groups using random allocation computer software. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients allocated into two groups according computer generated numbers, Blinding description: This study was a double-blind clinical trial. participants and researcher were unaware about the patient belonged to the intervention or control groups. The drug were injected by an anesthesia technician (other than the researcher) who was unaware of the content of the study. 3 Hypotension. Intervention 1: Intervention group: patients in the intervention group received 100 micrograms per hour of Phenylephrine infusion. Intervention 2: Control group: patients in the control group received 100 micrograms of normal saline. Yes - There is a plan to make this available What will be shared: The results of the study will be published as an article. When: After publishing the article To whom: Researchers Conditions: As published article Where to obtain: Corresponding author How to obtain: By email address of corresponding author Comments:
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) Pregnant women candidates for cesarean section under spinal anesthesia American Society of Anesthesiologists classification system I and II (ASA II and ASA II) no limit no limit Female Patients with classical hypertension Gestational hypertension Patients with pulmonary and cardiovascular diseases Patients with cerebrovascular disease Fetal abnormality I95 Hypotension Treatment - Drugs Placebo Intervention group: patients in the intervention group received 100 micrograms per hour of Phenylephrine infusion Control group: patients in the control group received 100 micrograms of normal saline Hypotension, which was considered as a decrease in systolic blood pressure by 80% of the baseline. Timepoint: Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention. Method of measurement: Blood pressure monitoring device. Hypertension was considered as an increase in systolic blood pressure above 120% of the baseline. Timepoint: Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention. Method of measurement: Blood pressure monitoring device. Nausea. Timepoint: Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention. Method of measurement: Interview. Vomiting. Timepoint: Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention. Method of measurement: Interview. Bradycardia (decrease in heart rate to less than 60 beats per minute). Timepoint: Before the intervention and in 5, 15, 25, 35 and 45 minutes after the intervention. Method of measurement: Heart rate monitoring device. Oroumia University of Medical Sciences Approved 2019-01-16 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)