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临床试验/CTRI/2021/07/035125
CTRI/2021/07/035125尚未招募3 期

Comparison of Norepinephrine and Phenylephrine infusion for prevention of hypotension after spinal anaesthesia in patients undergoing elective cesarean section

Dr Shridevi P Edigar1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年1月8日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
To compare the effectiveness of infusion of norepinephrine and infusion of phenylephrine for prevention of hypotension after spinal anaesthesia in elective cesarean section

研究概览

简要总结

This study is interventional prospective Randomised  Comparative Trial  aiming to study the efficacy and safety of infusion of norepinephrine and phenylephrine for prevention of hypotension after spinal anaesthesia in patirnts undergoing elective cesarean section in 84 patients . This study will be conducted in Dr S N Medical college and associated group of hospitals Jodhpur Rajasthan .The primary outcome is to compare the number of rescue boluses of ephedrine required to treat hypotension in both the groups.

This study will be conducted under guidance of my guide and there is no financial burden on patients.

This study is ethically justified by IEC Dr S N Medical college , Jodhpur Rajasthan.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women with singleton pregnancy with age between 18years and 40years and gestation period between 36weeks to 40 weeks who comes under The American Society of Anaesthesiologists physical status â…¡ who are undergoing cesarean section under spinal anaesthesia.

排除标准

  • 1.Refusal for study 2.allergic to local anaesthetics or study drug 3.infection at insertion site 4.use of cardiac medication or medication for blood pressure control ,cardiovascular disease,hypertensive disorders of pregnancy ,eclamsia 5.Gestation diabetes requiring insulin 6.History of post operative nausea and vomiting 7.History of chronic opioid use(chronic pain syndrome) 8.cesarean delivery for maternal and/or fetal distress.

结局指标

主要结局

To compare the effectiveness of infusion of norepinephrine and infusion of phenylephrine for prevention of hypotension after spinal anaesthesia in elective cesarean section

时间窗: To comapare number of rescue boluses of ephedrine 0.6 mg to treat hypotension in both the groups from the time of sub arachnoid block till completion of surgery

次要结局

  • Two compare the following between two groups(Hemodynamic parameters like heart rate,respiratory rate,spo2)

研究者

发起方
Dr Shridevi P Edigar
申办方类型
Other [Principal investigator ]

研究点 (1)

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