Effect Of Ondansetron On The Dose Of Ephedrine In Elective Cesarean Section Under Spinal Anaesthesia: A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total dose of Ephedrine required to maintain blood pressure in the two groups
研究概览
简要总结
Due to its rapid onset, dense sensory block, and safety benefits, spinal anaesthesia is the most preferred technique for elective caesarean sections. Up to 70% of parturients face maternal discomfort, nausea, vomiting and potential fetal distress due to one of the most common complication of spinal anaesthesia, hypotension.
To solve this, vasopressors like ephedrine are used to maintain maternal blood pressure and provide preservation of utero-placental perfusion.
A 5-HT3 receptor antagonist and a common drug for preventing nausea and vomiting, Ondansetron, is suggested to have additional hemodynamic benefits. Through relaxing the Bezold-Jarisch reflex (BJR), which causes bradycardia and vasodilation, Ondansetron is believed to reduce spinal anaesthesia-induced hypotension. With the persistent stabilization of hemodynamics, Ondansetron may result in reduced use of Ephedrine, and thus lessening side effects.
This study intends to determine whether Ondansetron alters the Ephedrine dosage needed to keep hemodynamic stability in elective caesarean sections with spinal anaesthesia. The objective is to better understand the management of spinal anaesthesia-induced hypotension and improve outcomes for both maternal and fetal health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women between ages 20-40 years -American Society of Anaesthesiologists Physical Status II -Planned elective Lower Segment Cesarean Section under spinal anaesthesia -Singleton pregnancies.
排除标准
- •Contraindications to spinal anaesthesia (e.g., blood clotting disorders, severe hypotension) -Allergies to ondansetron or local anaesthetics -History of pregnancy-induced hypertension, per-eclampsia, eclampsia.
- •Pre-existing heart conditions -Use of serotonin-modulating drugs -Failed Spinal Anaesthesia and it’s conversion to General Anaesthesia.
结局指标
主要结局
Total dose of Ephedrine required to maintain blood pressure in the two groups
时间窗: Intraopeartive duration of surgery
次要结局
- Umbilical artery pH(Cord blood gas analysis done once the baby is delivered)
- Incidence of Bradycardia and Hypotension(Intraoperative duration of surgery)
- Ondansetron’s impact on nausea, vomiting(Intraoperatively and in Post-Anaesthesia Care Unit.)
研究者
Moulya V Shetty
MS Ramaiah Medical College and Hospital