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临床试验/NCT03792906
NCT03792906已完成4 期

Norepinephrine for Management of Post-spinal Anesthesia Hypotension During Cesarean Delivery: a Comparison of Two Bolus Doses

Cairo University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年1月18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
入组人数
110
试验地点
1
主要终点
Rate of successful management of maternal hypotension

研究概览

简要总结

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

详细描述

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .

The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.

No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women
  • Scheduled for cesarean delivery

排除标准

  • Patients with severe cardiac dysfunction
  • Patients with low blood pressure
  • Patients with ante-partum bleeding

研究组 & 干预措施

Norepinephrine 6 mcg

Experimental

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

干预措施: Norepinephrine 6 mcg (Drug)

Norepinephrine 6 mcg

Experimental

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

干预措施: Norepinephrine infusion (Drug)

Norepinephrine 6 mcg

Experimental

Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion

干预措施: Bupivacaine hydrochloride (Drug)

Norepinephrine 10 mcg

Active Comparator

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.

干预措施: Norepinephrine 10 mcg (Drug)

Norepinephrine 10 mcg

Active Comparator

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.

干预措施: Norepinephrine infusion (Drug)

Norepinephrine 10 mcg

Active Comparator

Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion.

干预措施: Bupivacaine hydrochloride (Drug)

结局指标

主要结局

Rate of successful management of maternal hypotension

时间窗: 30 minutes after spinal anesthesia

number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus).

次要结局

  • Heart rate(2 hours after subarachnoid block)
  • Apgar score for evaluation of the activity of the fetus(10 minutes)
  • Incidence of reactive hypertension(30 minutes after spinal anesthesia)
  • Rate of successful management of severe maternal hypotension.(30 minutes after spinal anesthesia)
  • Systolic blood pressure.(2 hours after subarachnoid block)
  • Umbilical blood acidity(10 minutes after delivery)
  • The frequency of vomiting.(2 hours after subarachnoid block)
  • Incidence of bradycardia(2 hours after subarachnoid block)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hasanin

Assistant professor

Cairo University

研究点 (1)

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