Comparison of effect of Phenylephrine versus Norepinephrine infusion on umbilical arterial pH and maternal blood pressure during Spinal Anaesthesia for Caesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Umbilical arterial blood pH
研究概览
简要总结
This study is a prospective, randomized, double blind comparative study.It will compare the effect of prophylactic infusion of phenylephrine and norepinephrine on the umbilical arterial pH, maternal haemodynamics and neonatal outcome at birth.
Prophylactic infusion of the study drug will be started immediately after giving intrathecal injection according to randomly divided two groups.
Norepinephrine infusion was recently investigated as an alternative for prophylaxis of post spinal hypotension with minimal cardiac side effects. Norepinephrine has pharmacologic properties that suggest it may be useful alternative to phenylephrine.We hypothesize that norepinephrine may be suitable alternative vasopressor for maintaining maternal blood pressure with less negative effects on heart rate and cardiac output compared with phenylephrine, so in this study, we will compare the effect of phenylephrine and norepinephrine infusion at equipotent doses (20:1) on umbilical arterial pH and maternal blood pressure during spinal anaesthesia for elective caesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •a)Patients belonging to American Society of Anaesthesiologists I & II.
- •b)Age 18 – 35 years.
- •c)Patients with uncomplicated normal singleton term pregnancy scheduled for elective caesarean section under spinal anaesthesia.
排除标准
- •a)Patients with absolute / relative contra-indications for spinal anaesthesia.
- •b)Patient with pregnancy induced hypertension.
- •c)Patients suffering from intercurrent medical diseases (Cardiovascular, Cerebrovascular or renal).
- •d)Patients with history of allergy to any of the study drugs.
- •e)Patients having conditions such as oligohydroamnios, intrauterine growth restriction (IUGR) which can explain pre-existing foetal hypoxemia or neonatal acidemia.
- •f)Patients suffering from connective tissue disorders which reduce blood flow to the placenta such as systemic lupus erythematosus.
- •g)Patient refusal to participate in study.
结局指标
主要结局
Umbilical arterial blood pH
时间窗: Immediately after delivery
次要结局
- Apgar score; Umbilical vein blood pH; Maternal systolic and diastolic blood pressure; Mean arterial pressure; Maternal hypotension; Maternal heart rate; Reactive hypertension; Bolus of vasopressor; Side effects of drug(From spinal injection to delivery after every one minute)