A study to compare the effect of prophylactic infusion of two different doses of phenylephrine on maternal hypotension and neonatal outcome in females undergoing cesarean section under spinal anaesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50 micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia.
研究概览
简要总结
Spinal anaesthesia is nowadays preferred over General anaesthesia for caesarean sections as it not only overcomes the complications associated with general anaesthesia but also provides more effective pain control, early ambulation and better maternal and fetal outcomes.Intraoperative hypotension is defined as decrease in mean blood pressure less than 20% of patient’s baseline value. It can occur after spinal anaesthesia and may have deleterious effects on maternal and fetal outcomes.The effects of various vasopressors like ephedrine, nor-epinephrine, mephenteramine, phenylephrine, etc. have been studied in the prevention of spinal hypotension.Considering the influences on fetomaternal physiology like minimal placental passage, less incidence of fetoacidosis and maternal nausea, vomiting, etc. phenylephrine has been found to be the vasopressor of choice.Therefore we will be doing this random prospective study to compare two rates of infusion of phenylephrine (25 and 50 micrograms/minute) in preventing maternal hypotension caused by spinal anaesthesia and neonatal outcomes in patients undergoing caesarean section.
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
- •1.Patients with physical status ASA grade I or II.
- •2.All patients giving written informed consent.
- •3.Patients with gestation age > 36 weeks posted for elective caesarean delivery under spinal anaesthesia.
- •4.Patients belonging to age group of 18 to 35 years.
排除标准
- •1.Parturients with complications like risk of excessive bleeding (placenta previa, prolonged labor, abnormal presentation, multiple gestation) 2.Patients with pre-existing or pregnancy induced hypertension or maternal SBP< 100mm Hg. 3.Patients with cardiovascular disease, cerebrovascular disease, severe anemia or diabetes.
- •4.Patients with known fetal abnormalities.
- •5.Patients with contraindication to spinal anaesthesia.
- •6.Patients with known allergy to phenylephrine 7.Patients with inability or refusal to give informed consent.
结局指标
主要结局
To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50 micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia.
时间窗: From administration of spinal anaesthesia intraoperstively till the end of the surgery.
-To assess the changes in maternal blood pressure
时间窗: From administration of spinal anaesthesia intraoperstively till the end of the surgery.
-To assess the changes in maternal heart rate.
时间窗: From administration of spinal anaesthesia intraoperstively till the end of the surgery.
次要结局
- To assess the effect of prophylactic administration of two different infusion rates of phenylephrine (25 and 50• micrograms/minute) on maternal hemodynamics and neonatal outcomes in parturients undergoing caesarean section under spinal anaesthesia.(•To assess the incidence of nausea and vomiting)