A comparative study of efficacy of fixed dose bolus of 50 mcg for treatment of post spinal hypotension in pre-eclamptic and normotensive parturients undergoing lower segment cesarean section .
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Phenylephrine in treating hypotension
研究概览
简要总结
Spinal Anaesthesia is the gold standard for caesarean section as it has more advantages such as rapid onset, minimal transfer of drug to the fetus and less failure risks over general anaesthesia due to physiological changes of pregnancy. Normally, T4-T6 level of sensory block is required for smooth conduct of caesarean section. Intraoperative hypotension is the major complication of spinal anaesthesia. This can lead to reduced uteroplacental blood flow, foetal hypoxia and acidosis, and maternal side effects like nausea, vomiting, reduced consciousness. Management of post spinal anaesthesia includes intravenous fluids, leg compression or elevation, left uterine displacement.The mainstay of management is vasopressors like ephedrine, mephentermine, phenylephrine and norepinephrine 4.
Phenylephrine, a directly acting alpha 1 agonist, increases the Systolic and Diastolic blood pressure by causing vasoconstriction and is known to cause lesser foetal acidosis. Therefore, Phenylephrine administration is the preferred line of treatment for post spinal hypotension. Phenylephrine boluses in the range of 50-100 mcg have been used in normotensive parturients safely. However, in patients with pre-eclampsia the dose required is lower due to two factors - small foetus size which reduces aortocaval compression and diffuse endothelial dysfunction resulting in synthesis of vasodilators and increased response to vasoconstrictors. This effect may be more pronounced in pre eclamptics.
Currently, there are very few clinical studies on comparison of fixed dose of phenylephrine required for treating post spinal hypotension in pre- eclamptics and normotensives parturients in lower segment caesarean section surgeries, the aim of this study is comparison of efficacy of 50 mcg Phenylephrine in improving blood pressure in pre eclamptic and normotensive pregnant women undergoing caesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients between age 18-40 years with singleton pregnancy scheduled for caesarean section under spinal anaesthesia and who give written informed consent for study. American Society of Anaesthesiologists (ASA) Grade II BMI 18.
- •30 kg/m2 and Height 150-160 cm. Parturients with pre-eclampsia. Parturients who develop hypotension post spinal.
排除标准
- •Patients not willing to give consent Patients with known allergy to study drug Parturients with partial HELLP or HELLP syndrome.
结局指标
主要结局
To compare the efficacy of Phenylephrine in treating hypotension
时间窗: Baseline , 3 min, 6 min, 9 min, 12 min, 15 min, 18min, 21 min, 24min, 27 min, 30 min, 40 min, 50 min, 60 min
次要结局
- Umbilical artery blood pH(APGAR Score at 1 min and 5 min)
研究者
Dr Sargam Gupta
Bangalore Medical College and Research Institute