Effect of prophylactic infusions of phenylephrine and norepinephrine on uterine contractility and uterotonic requirements during elective caesarean section under spinal anaesthesia: A randomised double-blind comparison
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Total oxytocin dose requirement
研究概览
简要总结
This randomized, double-blind study will compare the effect of phenylephrine and norepinephrine on uterine contractility and uterotonic requirements during caesarean section in healthy consenting mothers with uncomplicated singleton, term pregnancy. One hundred and thirty consenting mothers undergoing caesarean section under spinal anaesthesia will be studied. After administration of spinal anaesthesia, phenylephrine or norepinephrine infusion will be titrated to maintain blood pressure. Oxytocin will be administered post-delivery, with dose adjustments and rescue uterotonics as needed. Oxytocin dose requirement, adequacy of uterine tone, additional uterotonics requirements, estimated blood loss, change in haemoglobin, incidence of postpartum haemorrhage and any side effects will be assessed. Intraoperative monitoring and postoperative follow-up for 24 hours will be conducted. Primary outcome will be oxytocin dose requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Consenting healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia.
排除标准
- •History suggestive of maternal complications e.g., pre-eclampsia, cardiovascular disease, cerebrovascular disease Known risk factors for postpartum haemorrhage e.g., multiple gestation, abnormal placentation, uterine fibroid, macrosomia, hydramnios, history of postpartum haemorrhage or uterine atony Patients on monoamine oxidase inhibitors or tricyclic antidepressants History suggestive of presence of mesenteric or peripheral vascular thrombosis Patients with absolute or relative contra-indications for spinal anaesthesia.
结局指标
主要结局
Total oxytocin dose requirement
时间窗: Intraoperative and 24 hours postoperative
次要结局
- Adequacy of uterine tone(Additional uterotonics used)
研究者
Dr Medha Mohta
University College of Medical Sciences and Guru Teg Bahadur Hospital