Comparison of phenylephrine and norepinephrine for treatment of spinal hypotension during elective caesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension on neonatal outcome by umbilical cord blood gas analysis
研究概览
简要总结
Spinal anaesthesia, technique of choice for Caesarean delivery, is associated with hypotension. Hypotension should be treated rapidly by administrationof vasoactive drugs. Phenylephrine, a α-adrenergic drug, is currentlythe vasopressor of choice for prevention and management of post spinalhypotension. However, phenylephrine has a dose-related tendency to decrease heartrate and cardiac output. Norepinephrine is a potent α-adrenergic receptoragonist, but unlike phenylephrine, it is also a relatively weak agonist atβ-adrenergic receptors. The study hypothesis isthat norepinephrine is a superior vasopressor as compared to phenylephrine fortreatment of post spinal hypotension in Caesarean delivery in terms of maternaland neonatal outcome. The aim of the present study is to compare the effect ofnorepinephrine and phenylephrine for treatment of maternal hypotension duringspinal anaesthesia in patients undergoing elective Caesarean delivery and tostudy the effects of these vasopressors on neonatal outcome (primary outcomemeasure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anaesthesiologists physical status I and II women
- •Term pregnancy
- •Singleton pregnancy
- •Scheduled for elective Caesarean delivery under spinal anaesthesia.
排除标准
- •Pre-existing or pregnancy induced hypertension
- •Diabetes Mellitus
- •Known cardiovascular or cerebrovascular disease
- •Foetal abnormality
- •Onset of labour
- •Allergy to any study medication
- •Weight less than 50 kg or more than 100 kg.
结局指标
主要结局
To evaluate the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension on neonatal outcome by umbilical cord blood gas analysis
时间窗: At time of delivery of baby
次要结局
- 1. To evaluate and compare the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension in patients undergoing elective Caesarean delivery (maternal outcome).(2. To evaluate the effect of bolus administration of PE and NE on neonatal outcome on Apgar scores and neurobehavioral response evaluation.)