A comparison of different doses of phenylephrine bolus injections in treatment of post spinal hypotension in pre eclampsia patients undergoing LSCS- RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of episodes of hypotension after giving the first dose of phenylephrine
研究概览
简要总结
Hypotension following spinal anesthesia in obstetric patients is a common complication with incidence as high as 80 percent. Unless urgently treated, it might lead to fetal hypoxic stress and acidosis due to reduced uteroplacental blood flow and reduced cardiac output in mother with catastrophic effects on both mother and fetus..
Vasopressors are the mainstay in the management of hypotensionassociated with spinal anesthesia. Commonly used vasopressors are Ephedrine, Mephenteramine and phenylephrine with different benefits. Phenylephrine, a pure alpha agonist is the first line vasopressor in treatment of hypotension in normotensive patients , both as bolus and infusion. Phenylephrine boluses in dose range of 50-100µg have been used in both normotensive and pre eclamptic patients but the optimum dose is not yet proved. High doses are reported to cause maternal hypertension, bradycardia and decrease in cardiac output whereas lower dose may be associated with repeated dosing . Compared to healthy patients, the dose requirement of phenylephrine in pre eclamptic patients is expected to be lower due to smaller fetus and diffuse endothelial dysfunction with decreased synthesis of vasodilators but increased sensitivity of vasoconstrictors .
There is inadequate literature on the effective dose of phenylephrine as bolus injection in preeclampsia patients to treat post spinal hypotension. Hence, we intend to study two different doses of phenylephrine bolus injections in treatment of post spinal hypotension in Pre-eclampsia patients undergoing LSCS.
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
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient providing written informed consent voluntarily patient of 19-40 yrs American society of anesthesiologist grade 2 patient newly diagnosed to have Pre-eclampsia patient of pre eclampsia on treatment patient with weight 50- 80 kgs height of
- •170cm patient with pre eclampsia undergoing elective or emergency lower segment cesarean section in uncomplicated pregnancies under spinal anesthesia patient who develop hypotension following spinal anesthesia.
排除标准
- •Patients with ASA III or higher Allergic to the study drug Complicated Pregnancies -Multiple pregnancy, preterm LSCS, umbilical cord prolapse, HELLP, Eclampsia, Antepartum hemorrhage Bad obstetric history Inadequate level of spinal anesthesia Fetal growth restriction (estimated fetal weight less than 3rd centile for given gestational age [8]) Pre-existing HTN, Cerebral disease, Raised ICP, Severe PIH GDM, Epilepsy, Cardiac disease, Congestive heart failure resting heart rate less than 60 bpm Fetal anomalies in obstetric scans.
结局指标
主要结局
Number of episodes of hypotension after giving the first dose of phenylephrine
时间窗: Blood pressure , heart rate , saturation will be monitored at an interval of 3 mins
次要结局
- Increase in MAP following the first dose of phenylephrine(MAP measured immediately after administration of phenylephrine and and after 3 minutes of admisnistration)
研究者
Sankar R Nair
Bangalore medical college and research institute