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IRCT2015070920588N3 IRCT 2015-11-12 Vce chancellor for research of Isfahan University of Medical Scienses Comparison of Phenylephrine and Ephedrine in the treatment of hypotension Comparison of Phenylephrine and Ephedrine in the treatment of hypotension after spinal anesthesia 2015-02-20 anticipated 110 Complete https://irct.ir/trial/18232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Hypotension. Intervention 1: Intervention group-1 :Will receive 50μg Phenylephrine(group P) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused. Intervention 2: Intervention group-2 :Will receive 5mg Ephedrine(group E) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused.
public Darioush Moradi
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3362 5555 dmoradi@med.mui.ac.irdrdmoradi@gmail.com Isfahan University of Medical Sciences scientific Darioush Moradi
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
Isfahan Iran (Islamic Republic of) +98 31 3362 5555 dmoradi@med.mui.ac.irdrdmorsdi@gmail.com Isfahan University of Medical Sciences Iran (Islamic Republic of) inclusion criteria: 110 patient with ASA physical status class I-II aged 40-65 years who are candidates of lower extremity orthopedic surgery. Exclusion criteria:Any hypersensitivity reaction to vasopressore or local anesthetic drugs, systemic diseases like cardiovascular, liver, or renal diseases and pregnancy. 40 years 65 years Both 195.2 Hypotension due to drugs Treatment - Drugs Treatment - Drugs Intervention group-1 :Will receive 50μg Phenylephrine(group P) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused. Intervention group-2 :Will receive 5mg Ephedrine(group E) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused. Systolic blood pressure. Timepoint: 2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room. Method of measurement: Noninvasive Blood pressure monitoring system. Diastolic blood pressure. Timepoint: 2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room. Method of measurement: Noninvasive Blood pressure monitoring system. Mean arterial blood pressure. Timepoint: 2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room. Method of measurement: Noninvasive Blood pressure monitoring system. Heart rate. Timepoint: 2 ،4 ، 6 ، 8 ، 10 ، 14 ، 20 and 30 minutes after arrival of the patient to the recovery room. Method of measurement: pulse oxymetery. Arterial blood oxygen saturation. Timepoint: 2 ،4 ، 6 ، 8 ، 10 ، 14 ، 20 and 30 minutes after arrival of the patient to the recovery room. Method of measurement: pulse oxymetery. Drug and non drug related complications. Timepoint: Any time during the study. Method of measurement: clinical evaluation. Vce chancellor for research of Isfahan University of Medical Scienses Approved 2014-12-11 Isfahan University of Medical Sciences Research Deputy, Isfahan university of medical sciences, Hezarjrib Street, Isfahan, Iran Isfahan Iran (Islamic Republic of)