Comparison of prophylactic intravenous bolus versus infusion of phenylephrine for preventing spinal anesthesia-induced hypotension in elective cesarean sections
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- to assess the effect of
研究概览
简要总结
INTRODUCTION: Spinal block is the preferred choice of anesthesia for cesarean sections due to its efficacy and safety profile. However, it can lead to sympathetic nerve block, reducing peripheral vascular resistance and causing hypotension. Various interventions can be employed to correct this hypotension, such as adjusting the dose of the anesthetic agent, and administering vasoactive medications. Phenylephrine is the first-line drug used to manage hypotension resulting from spinal anesthesia.
AIM: To evaluate the effect of prophylactic doses of intravenous bolus versus infusion of phenylephrine for the prevention of spinal-induced hypotension in elective cesarean sections. Objective of the study is to compare the effectiveness of prophylactic intravenous bolus versus infusion of phenylephrine in preventing spinal-induced hypotension in elective cesarean sections.
METHODOLOGY: An interventional, open label study will be conducted on all patients who are undergoing lower segment cesarean section from July 2024 to December 2025 will be devided in to two groups i.e. Group A will receive continuous IV infusion of phenylephrine at 0.15 mcg/kg/min and Group B will recieve Single IV bolus dose of phenylephrine 50 mcg.
SIGNIFICANCE: This study aims to determine the most effective prophylactic administration method of phenylephrine for preventing spinal-induced hypotension in elective cesarean sections, thus improving maternal and fetal outcomes.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •All the patients who are undergoing cesarean section or the patients falling under American Society of Anesthesiology (ASA) Grade II.
排除标准
- •Contraindications to regional anesthesia such as anatomic disorders of spine, shock, local site infections, peripheral neuropathy.
- •Patients with the history of hypertension or pregnancy induced hypertension.
- •3.Patients with hypersensitivity to study drugs .
- •4.Patients with coagulation disorders and bleeding disorders.
- •5.Patients with cardiovascular or cerebrovascular disorders
- •Patients with fetal abnormality.
结局指标
主要结局
to assess the effect of
时间窗: Continuous intraoperative, vitals will be recorded every 2min interval for first 10min and then at 5 min interval till the end of surgery. outcome will also be assessed in post anaesthetic care unit (PACU) at | 15min interval.
prophylactic doses of intravenous bolus versus infusion of phenylephrine for prevention
时间窗: Continuous intraoperative, vitals will be recorded every 2min interval for first 10min and then at 5 min interval till the end of surgery. outcome will also be assessed in post anaesthetic care unit (PACU) at | 15min interval.
of spinal induced hypotension in elective cesarean section.
时间窗: Continuous intraoperative, vitals will be recorded every 2min interval for first 10min and then at 5 min interval till the end of surgery. outcome will also be assessed in post anaesthetic care unit (PACU) at | 15min interval.
次要结局
- To assess intaoperative complications related to study drug.(To calculate apgar scoreat 1 and 5 minute respectively.)
研究者
Dr Anita Kumari
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar