CTRI/2023/06/054376尚未招募4 期
Comparison of prophylactic infusion of norepinephrine and phenylephrine for the maintenance of hemodynamics following subarachnoid block during cesarean section: an interventional double blind randomised trial
Dr Y Surekha1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年10月7日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To compare the incidence of bradycardia among phenylephrine and norepinephrine groups
研究概览
简要总结
This is a type of randomised double blind interventional study where norepinephrine and Phenylephrine infusions will be given prophylactically in less dose and comparing those two drugs and observing which will prevent bradycardia in parturients undergoing cesarean section. Totally 2 groups, each group containing 64 persons. So total sample size will be 128 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients with uncomplicated term singleton pregnancy undergoing elective cesarean delivery and belonging to American Society of Anaesthesiologists classification 2 2) Age 18 to 35 yrs 3) Parturients giving informed written and valid consent.
排除标准
- •parturients having hypertensive disorders of pregnancy, diabetes milletus, cardiac, cerebrovascular, renal disorders, oligohydramnios, IUGR.
- •parturients having hypersensitivity to any of the study drugs 3) parturients with known contraindications to spinal anaesthesia.
结局指标
主要结局
To compare the incidence of bradycardia among phenylephrine and norepinephrine groups
时间窗: Measuring HR every 1 minute from onset of spinal action till delivery of baby
次要结局
- Incidence of hypotensive episodes, maternal systolic and diastolic blood pressure, MAP,number of boluses of vasopressors required, reactive hypertension.(Measuring, BP and MAP every one minute from onset of spinal anaesthesia to delivery of the baby)
研究者
研究点 (1)
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