]>
IRCT2015050622131N1 IRCT 2015-09-19 Vice Chancellor Of Research Zahedan University Of Medical Sciences Comparison of Intravenous Phenylephrine and Ephedrine to Treat Hypotension Associated with Spinal Anesthesia in Patients Undergoing Cesarean Section Comparison of Intravenous Phenylephrine and Ephedrine to Treat Hypotension Associated with Spinal Anesthesia in Patients Undergoing Cesarean Section 2015-07-23 anticipated 120 Complete https://irct.ir/trial/19165 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Maternal hypotension. Intervention 1: Bolus injection of 5 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 5 mg. Intervention 2: Bolus injection of 10 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose,10 mg. Intervention 3: Bolus injection of 50µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 50µg. Intervention 4: Bolus injection of 100 µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 100 µg.
public Hedayatollah Vakili
Ali- ebn- Abitaleb hospital operating room in Zahedan
Zahedan Iran (Islamic Republic of) 9816883883 +98 71 3843 8875 vakili_h@sums.ac.ir Zahedan University of Medical Sciences scientific Hassan Enayati
Ali- ebn- Abitaleb hospital operating room in Zahedan
Zahedan Iran (Islamic Republic of) +98 54 3322 3001 enayati_hassan@yahoo.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:Pregnant women 2o-35 years old ;Elective cesarean;ASA1; Singleton pregnancy;36 to 40 weeks gestational age;Weighing 45 to 90 kg;145 to 180 cm height;Informed consent for inclusion Exclusion criteria beginning: History of Primary hypertension (Bp≥140/90);cardio-cerebrovascular diseases; Diabetic mellitus;Sensitivity to anesthetics;Pregnancy complications such as gestational hypertension;Placental abnormalities;Umbilical cord abnormalities;High-risk pregnancies(Multiple pregnancy،Intrauterine growth retardation);Spinal anesthesia ban(Prevention of spinal anesthesia،Coagulation disorder،Infection of spinal anesthesia area);Lack of consent to participate in the study Exclusion criteria during the study:Unpredictable events during surgery such as abnormal hemorrhage under surgery; unsuccessful spinal anesthesia;high spinal Anesthesia (at level above T4); more than 75min surgery duration 20 years 35 years Female o26.5 Maternal hypotension syndrome Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Bolus injection of 5 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 5 mg Bolus injection of 10 mg ephedrine if hypotension is more than 20% from baseline and If necessary, repeat dose,10 mg Bolus injection of 50µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 50µg Bolus injection of 100 µg phenylephrine if hypotension is more than 20% from baseline and If necessary, repeat dose, 100 µg Blood pressure. Timepoint: After spinal anesthesia,75 minutes (every 3 minutes for the first 15-minute period and every 10 minutes for the following 60-minute period. Method of measurement: mmHg by SIEMENS SC 7000 monitoring system. Heart rate. Timepoint: After spinal anesthesia, were checked for 75 minutes (every 3 minutes for the first 15-minute period and every 10 minutes for the following 60-minute period. Method of measurement: Number by SIEMENS SC 7000 Monitoring system. Base Exess. Timepoint: After the extraction of fetus and umbilical cord clamp. Method of measurement: Number -Based on the arterial umbilical cord Base Exess,that was measured by blood gas analyzer ,GASTAT-603ie. Nausea. Timepoint: During Surgery. Method of measurement: Has/has not,Patient-reported. Vomiting. Timepoint: During Surgery. Method of measurement: Has/has not,Observer-reported. Umbilical cord Ph. Timepoint: After the extraction of fetus and umbilical cord clamp. Method of measurement: Number -Based on the arterial umbilical cord PH,that was measured by blood gas analyzer ,GASTAT-603ie. Neonatal Apgar. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Based on clinical examination. Vice Chancellor Of Research Zahedan University Of Medical Sciences Approved 2015-06-14 Zahedan University of Medical Sciences Zahedan Medical Sciences University campus office complex,Khalij e Fars Avenue,Dr.Hesabi Square,Zahedan.Iran zahedan Iran (Islamic Republic of)