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临床试验/NCT07067944
NCT07067944已完成不适用

The Preventive Role of Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized, Prospective Double-blinded Study

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Maternal systolic blood pressure

研究概览

简要总结

This study aimed to compare the effects of prophylactic ephedrine and nor-epinephrine infusion on maternal hemodynamics and neonatal outcomes following spinal anesthesia in cesarean deliveries.

详细描述

Neuraxial anesthesia for cesarean delivery (CD) has significantly reduced maternal mortality by avoiding Manipulation of the airway, the mother being awake, and promoting early bonding of mother and child, adequate Postoperative analgesia, and quicker maternal recovery.

Systemic vascular resistance decreases as a result of a reduction in sympathetic tone of the arterial circulation, leading to peripheral arterial vasodilation, the extent of which depends on the number of spinal segments involved. Other theories are proposed to explain hypotension during spinal anesthesia, among them: 1)direct depressive circulatory effect of local anesthetics, 2) relative adrenal insufficiency, 3) skeletal muscle paralysis, 4) ascending medullary vasomotor block, and 5) concurrent mechanical respiratory insufficiency. Loss of sympathetic input to the heart, leaving vagal parasympathetic innervations unopposed, and a decrease in cardiac preload are the main reasons for bradycardia during spinal anesthesia.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age more than 21 years.
  • American Society of Anesthesiologists Physical Status II and III.
  • Full-term singleton pregnant women scheduled for elective cesarean section under spinal anesthesia.

排除标准

  • Morbid obesity [body mass index (BMI)>40].
  • Diabetes Mellitus.
  • Severe cardiovascular disease.
  • Hypertensive disorders of pregnancy.
  • Chronic kidney disease.
  • Non-assuring fetal status.
  • Peripartum bleeding.

研究组 & 干预措施

Group A

Experimental

The parturient will receive ephedrine infusion immediately before intrathecal injection till delivery of the baby at a dose of 4mg /min.

干预措施: Ephedrine (Drug)

Group B

Experimental

The parturient will receive noradrenaline infusion immediately before intrathecal injection till delivery of the baby at a dose of 4 microgram/minute.

干预措施: Noradrenaline (Drug)

结局指标

主要结局

Maternal systolic blood pressure

时间窗: 10 minutes after induction of spinal anesthesia

Maternal systolic blood pressure was recorded 10 minutes after induction of spinal anesthesia.

次要结局

  • Number of needed rescue boluses of vasopressors(After induction of spinal anesthesia (Up to 2 hours))
  • Heart rate(Intraoperatively)
  • Incidence of adverse events(2 hours after induction of spinal anesthesia)
  • APGAR score(5 minutes after delivery)

研究者

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

Hadeer Gamal Fouda

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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