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临床试验/CTRI/2024/12/078469
CTRI/2024/12/078469尚未招募不适用

Comparison of two different doses of prophylactic Norepinephrine in patients undergoing elective caesarean section to prevent post spinal Anesthesia Hypotension: A Randomised study

All India Institute of Medical Scienes, Bibinagar1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年1月3日最近更新:

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
Number of hypotensive episodes between two groups.

研究概览

简要总结

Prophylactic infusion of vasopressors with a rescue bolus dosing was observed to be more effective for hemodynamic stability when compared to administering bolus dose alone. With norepinephrine 0.04mcg/kg/min, there is decreased incidence(77.9%) of maternal hypotension. Still 22.1% of the patients were getting hypotension even with prophylactic norepinephrine infusion at 0.04mcg/kg/min. so we hypothetise that doubling the dose of norepinephrine prophylactic infusion can lead to 50% decrease in incidence of hypotension compared to 0.04mcg/kg/min. In this study, we compared two different doses of norepinephrine 0.04 mcg/kg/min(group A) and 0.08 mcg/kg/min(group B).

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 35.00 Year(s)(—)
性别
Female

入选标准

  • ASA II Uncomplicated normal singleton beyond 36 weeks term pregnancy scheduled for lower segment caesarean section under spinal anesthesia.

排除标准

  • BMI more than 40 Multiple gestation Emergency caesarean Gestational hypertension Gestational diabetes mellitus Cardiovascular, cerebrovascular or renal disease Oligohydromnios Intrauterine growth restriction.

结局指标

主要结局

Number of hypotensive episodes between two groups.

时间窗: Till the end of surgery

次要结局

  • Number of rescue boluses, hemodynamic parameters, APGAR score, nausea and vomiting between two groups

研究者

发起方
All India Institute of Medical Scienes, Bibinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Devarakonda Sai Manoj

AIIMS BIBINAGAR

研究点 (1)

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