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临床试验/NCT06512402
NCT06512402尚未招募不适用

Epinephrine Versus Norepinephrine Infusion for Prevention of Maternal Hypotension During Caesarean Delivery: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2024年8月最近更新:
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
212
试验地点
1
主要终点
incidence of post-spinal hemodynamic instability

研究概览

简要总结

Epinephrine is a well-known vasoactive agent in medical practice. However, its use is obstetric population is still scanty. Few studies evaluated the use of epinephrine during Cesarean delivery and a recent randomized controlled dose-finding trial reached an acceptable incidence of hypotension (13%) with the use of 0.03 mcg/kg/min as prophylaxis.

Being a newly introduced vasoactive agent in obstetric practice, it is essential to be adequately compared with other vasopressors using the optimum dosage and appropriate outcomes.

There are no data, till date, comparing epinephrine versus norepinephrine infusion during Cesarean delivery using a composite outcome of hypotension, hypertension, and bradycardia. The aim of this study is to compare epinephrine versus norepinephrine infusion for prophylaxis against post-spinal hypotension during Caesarean delivery

详细描述

Upon arrival to the operating room, routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and 10 mg metoclopramide, and 50 mg ranitidine will be delivered. Co-load infusion of lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes; and 10 mg hyperbaric bupivacaine in addition to 20 mcg fentanyl will be injected in the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive the vasopressor infusion according to the allocated study group Block success will be assessed after 5 minutes from injecting local anesthetic into the subarachnoid space using pinprick; and will be confirmed if sensory block level is at T4. The vasopressor will be infused in the same line with intravenous fluids using a three-way stopcock. The baseline systolic blood pressure reading will be calculated as the average of 3 readings obtained in the supine position with left-uterine displacement at two-minute intervals with a difference of <10%.

Hemodynamic management in both groups will be as follow:

Post-spinal hypotension (defined as systolic blood pressure ≤80% of the baseline reading or systolic blood pressure <90 mmHg during the period from intrathecal injection to delivery of the fetus) will be managed by ephedrine 9 mg Severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) will be managed by administration of ephedrine 15 mg Reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading) will be managed (if persisted > 1-reading) by stoppage of the infusion till the next systolic blood pressure reading.

Intraoperative bradycardia (defined as heart rate less than 55 bpm) will be managed by stoppage of the vasopressor infusion if not associated with hypotension. The infusion will be then re-started in a reduced rate (50%) when the heart rate is more than 55 bpm. IV atropine bolus (0.5 mg) will be administered if bradycardia persisted despite stoppage of the infusion. If accompanied with hypotension, bradycardia will be managed by IV bolus of ephedrine 9 mg.

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

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

  • full-term singleton pregnant women, admitted for elective cesarean delivery

排除标准

  • Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
  • hypertensive disorders of pregnancy,
  • peripartum bleeding,
  • coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
  • baseline systolic blood pressure (SBP) < 100 mmHg

研究组 & 干预措施

Norepinephrine group

Active Comparator

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive norepinephrine infusion until 5 min after delivery

干预措施: Norepinephrine (Drug)

Epinephrine group

Active Comparator

After subarachnoid block, mothers will be placed in supine position with left-lateral tilt and will receive epinephrine infusion until 5 min after delivery

干预措施: Epinephrine (Drug)

结局指标

主要结局

incidence of post-spinal hemodynamic instability

时间窗: 1 min after spinal anesthesia until 5 min after the delivery

the occurrence of either, hypotension, hypertension, bradycardia, and/or tachycardia

次要结局

  • umbilical pH(5 min after delivery)
  • heart rate(1 min after spinal anesthesia until 5 min after the delivery)
  • systolic blood pressure(1 min after spinal anesthesia until 5 min after the delivery)
  • Apgar(5 min after delivery)

研究者

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

Ahmed Hasanin

Principal Investigator

Cairo University

研究点 (1)

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