Comparison of nebulised Phenylephrine and nebulised Norepinephrine for prevention of Post Spinal Hypotension in patients undergoing Elective Caesarean delivery: A double blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Incidence of Post spinal hypotension after receiving prophylactic nebulised dose of phenylephrine and norepinephrine in patient undergoing elective caesarean section
研究概览
简要总结
Post spinal hypotension is a common and potentially serious complication in patients undergoing elective caesarean delivery under spinal anaesthesia. It can lead to significant maternal and fetal morbidity if not effectively managed. Traditionally, vasopressors such as phenylephrine and norepinephrine are utilized to mitigate this issue due to their vasoconstrictive properties, which help maintain blood pressure. However, the optimal choice of vasopressor remains a subject of ongoing debate.
Phenylephrine, a selective alpha-1 adrenergic receptor agonist, is widely used and well-documented for its efficacy in maintaining hemodynamic stability during spinal anaesthesia. Nevertheless, it is associated with reflex bradycardia and decreased cardiac output, which can be detrimental in some cases. On the other hand, norepinephrine, which acts on both alpha and beta-adrenergic receptors, has gained attention for its potential to provide more balanced hemodynamic support with less impact on heart rate and cardiac output.
This double-blind randomized controlled study aims to compare the efficacy and safety of nebulised phenylephrine versus nebulised norepinephrine in preventing post spinal hypotension in patients undergoing elective caesarean delivery. By evaluating the hemodynamic profiles, maternal and fetal outcomes, and potential side effects of these two vasopressors, this study seeks to provide evidence-based guidance for optimizing maternal care during caesarean sections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women undergoing elective caesarean section under spinal anaesthesia.
排除标准
- •Patient refusal, Patient Allergic or hypersensitive to phenylephrine or norepinephrine, Preterm pregnancy, Twin pregnancy, ASA III, IV patient, Preeclamptic patient, Patient undergoing emergency caesarean section.
结局指标
主要结局
Incidence of Post spinal hypotension after receiving prophylactic nebulised dose of phenylephrine and norepinephrine in patient undergoing elective caesarean section
时间窗: Till the end of the operation
次要结局
- • Neonatal APGAR score(At 1 mins, 5 mins)
- • Any change in neonatal umbilical venous sampling for blood gas analysis.(Just after delivery)
- • Requirement of IV bolus dose of Phenylephrine (50 mcg)(During caesarean section)
- • Total volume of crystalloids (ml)(During caesarean section)
- • Any adverse events like nausea, vomiting and shivering(During caesarean section)
- • Incidence of reflex bradycardia(During caesarean section)
研究者
Chirag Bhati
All India institute of medical sciences Patna