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临床试验/NCT05368415
NCT05368415已完成4 期

Comparison Between Different Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome

研究概览

简要总结

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .

The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant female with preeclampsia
  • age 18-40

排除标准

  • age less than 18
  • age above 40
  • patient refusal of spinal anesthesia
  • patient with eclampsia
  • patient allergy to anesthesia drugs or to NE

研究组 & 干预措施

5 mcg group

Active Comparator

this group will receive Norepinephrine bolus of 5 mcg for management of hypotension

干预措施: Norepinephrine (Drug)

3 mcg grup

Active Comparator

this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.

干预措施: Norepinephrine (Drug)

4 mcg group

Active Comparator

this group will receive Norepinephrine bolus of 4 mcg for management of hypotension

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Neonatal concentration of HCO3 from a sample of umbilical cord as a surrogate of neonatal outcome

时间窗: up to 5 minutes after delivery

measuring HCO3 from umbilical cord blood gases analysis

次要结局

  • Rate of successful management of maternal hypotension(2 minutes after NE bolus)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Sayed Arafa

lecturer of anesthesia and surgical ICU

Kasr El Aini Hospital

研究点 (1)

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