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IRCT201601238768N4 IRCT 2016-10-09 Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences Evaluation of the effect of phenylephrine on spinal anesthesia induced hypotension in cesarean section Comparison between different prophylactic & therapeutic phenylephrine regimenes in reducing maternal hypotention after induction of spinal anesthesia in caesarean section 2016-10-22 anticipated 120 Complete https://irct.ir/trial/9259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 spinal anesthesia induced hypotension. Intervention 1: Intervention1: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) 100 microgram phenylephrin in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected. Intervention 2: Intervention 2: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of phenylephrine 50 microgram per minute will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected. Intervention 3: Control group: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected.
public Mahshid Nikooseresht M.D
Anesthesiolgy Department, Besat hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
Hamadan Iran (Islamic Republic of) 6514845471 +98 81 3264 0049 nikooseresht@umsha.ac.ir Hamadan University of Medical Sciences scientific Mahshid Nikooseresht M.D
Anesthesiolgy Department, Besat Hospital, Shahid Motahari Blvd, Resalat Square, Hamadan
Hamadan Iran (Islamic Republic of) 6514845471 +98 81 3264 0050 nikooseresht@umsha.ac.ir Hamadan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: All of the ASA 1 healthy term parturients referring to Fatemieh hospital candidate for Cesarean section were included in the study. Exclusion criteria: chronic hypertension; pre eclampsia; twin pregnancy;, preterm labor; allergy to drugs; cardiovascular disease; renal disease and previous abdominal surgeries with adhesion band and fibrosis. 16 years 50 years Female O74.6 Other complications of spinal and epidural anaesthesia during labour and delivery Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention1: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) 100 microgram phenylephrin in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected. Intervention 2: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of phenylephrine 50 microgram per minute will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected. Control group: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected. Spinal anesthesia induced blood pressure change. Timepoint: before performing spinal anesthesia, every 2 minutes until delivery and then every 5 minutes until the end of surgery. Method of measurement: blood pressure was measured with automatic blood pressure device and hypotension was defined as more than 20% decrease of BP compared to baseline. Heart rate. Timepoint: before performing spinal anesthesia and then every 5 minutes until the end of surgery. Method of measurement: Electrocardiogram monitoring. Nausea. Timepoint: every 5 minutes until the end of surgery. Method of measurement: observation. Vomiting. Timepoint: every 5 minutes until the end of surgery. Method of measurement: observation. Rescue vasopressor dose. Timepoint: at the end of surgery. Method of measurement: measurement. Neonatal condition. Timepoint: at min 1 and 5. Method of measurement: Apgar score mesurements by observation and physical examination. Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences Approved 2016-01-23 Committee of Ethics in Research, Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan Hamedan Iran (Islamic Republic of)