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临床试验/NCT06213935
NCT06213935尚未招募不适用

Preoperative Oral Midodrine Versus Intraoperative Intravenous Norepinephrine in Preventing Post-spinal Anesthesia Hypotension in Cesarean Section: A Prospective Double-blind Randomized Clinical Trial

Sohag University0 个研究点目标入组 90 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
主要终点
Incidence of post spinal anesthesia hypotension

研究概览

简要总结

Neuraxial blockade such as spinal anaesthesia can cause severe hypotension due to pharmacological sympathectomy resulting in potential deleterious consequences for the patient, Prevention of this spinal anaesthesia induced hypotension is of utmost importance, Techniques currently in use for preventing hypotension include intravenous fluid prehydration, sympathomimetic drugs, and physical methods such as positioning and leg compression.

Midodrine is an orally active α-adrenergic agonist ,Used in clinical management of patients with orthostatic hypotension or hypotension secondary to other clinical conditions or drug therapies. Midodrine is almost completely absorbed after oral administration and undergoes enzymatic hydrolysis to form its pharmacologically active metabolite, de-glymidodrine , causes venous and arterial vasoconstriction through stimulation of α1- receptors located in the vasculature, However ,Midodrine may cause several side effects as chills ,numbness , tingling ,paresthesia ,polyuria ,dysuria and headache.

On the other hand, Norepinephrine is a vasoconstrictor that predominantly stimulates α1 receptors to cause peripheral vasoconstriction and increase blood pressure. It also has some β1 receptor agonist activity that results in a positive inotropic effect on the heart at higher doses. Norepinephrine also may cause side effects as headache, blurred vision, chest pain ,nervousness, bradycardia or tachycardia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The study will include 90 adult female patients, 45 in each group (between 18-35 years old).
  • patients of ASA physical status class I and class II.
  • patients scheduled for elective cesarean section under spinal anesthesia.

排除标准

  • Patient refusal.
  • Contraindication to spinal anesthesia .
  • Patients known allergic to Midodrine or Norepinephrine.
  • Patients with preexisting cardiovascular or cerebrovascular disease.
  • Patients with diabetes mellitus.
  • Patients with psychiatric disease or on psychiatric treatment.

研究组 & 干预措施

group A

Active Comparator

will receive a norepinephrine bolus at 0.05 μg/kg, followed by norepinephrine infusion at a rate of 0.05 μg/kg.min

干预措施: Norepinephrine (Drug)

Group B

Active Comparator

will receive 10 mg tablets of midodrine 1 hour before spinal anesthesia.

干预措施: Midodrine (Drug)

结局指标

主要结局

Incidence of post spinal anesthesia hypotension

时间窗: within 60 minutes of induction of spinal anesthesia

decrease in Mean Arterial Blood Pressure more than 20% of the baseline reading

次要结局

  • Intraoperative ephedrine consumption(within 60 minutes of induction of spinal anesthesia)
  • Incidence of post spinal anesthesia bradycardia(within 60 minutes of induction of spinal anesthesia)

研究者

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

Andrew Ramsis Khalafallah

Resident of Anesthesia,Intensive Care and Pain control department, Sohag university hospital

Sohag University

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