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临床试验/NCT07363109
NCT07363109尚未招募不适用

Prevention of Hypotension During Elective Cesarean Section Under Spinal Anaesthesia With Fixed-rate Metaraminol Infusion Versus Fixed-rate Norepinephrine Infusion: A Double-blind Randomised Controlled Clinical Trial.

Aretaieion University Hospital0 个研究点目标入组 80 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
incidence of hypotension

研究概览

简要总结

The aim of this double-blind randomised study will be to compare a fixed-rate prophylactic metaraminol infusion to a fixed-rate prophylactic norepinephrine infusion during elective cesarean section under combined spinal-epidural anaesthesia.

详细描述

Spinal anaesthesia is the anaesthetic technique of choice for elective cesarean section.

Spinal anaesthesia can be complicated by hypotension, with incidence exceeding 80% occasionally. Hypotension can lead to nausea, emesis and a subjective feeling of discomfort due to cerebral hypoperfusion. If left untreated, severe or sustained hypotension can lead to decreased uteroplacental flow and fetal distress of premature or compromised fetuses while severe complications to the parturient might ensue, such as loss of consciousness, aspiration, apnea or cardiac arrest.

Prophylactic vasoconstrictor infusion is an effective strategy for preventing maternal hypotension during regional anaesthesia. Phenylephrine is widely used because it acts quickly and causes less neonatal acidosis than ephedrine, but high doses may reduce maternal cardiac output. Norepinephrine and metaraminol, a sympathomimetic amine that acts both directly and indirectly, mainly by stimulating alpha-1-adrenergic receptors, with a weak effect on beta-receptors, have emerged as potential alternatives. While the optimal norepinephrine infusion dose has been defined in several studies, research on metaraminol remains limited, with insufficient data on its ideal dosing and efficacy in obstetrics. Most comparative studies evaluate metaraminol against phenylephrine-some suggesting better fetal acid-base outcomes-but no studies directly compare metaraminol with norepinephrine. Further research is therefore needed before metaraminol can be routinely recommended in obstetric anaesthesia.

This study will include pregnant adults who are normotensive, without complications, with a single pregnancy, who are not in active labor, and who are scheduled to undergo an elective cesarean section at the Gynecology-Obstetrics Clinic of Aretaieion Hospital.The study will use randomized, concealed allocation to assign participants to receive either metaraminol or norepinephrine infusions. Study group allocation will take place according to a computer-generated sequence of random numbers. A non-involved healthcare professional will reveal each participant's assignment, and a nurse will prepare identical 50 mL syringes labeled "study infusion," containing the drug at concentrations that deliver either 100 µg/min (200 µg/mL at 30 mL/h) of metaraminol or 4 µg/min (8 µg/mL at 30 mL/h) of norepinephrine. The anaesthesiologist, patient, and data analyst will remain blinded to group allocation.

All parturients will receive standard pre-anesthetic evaluation and standard hemodynamic monitoring will be applied. Next, on the hand opposite the one with the cuff for measuring NIBP, a special finger cuff connected to the Edwards Lifesciences ClearSight system will be placed on the index, middle, or ring finger. The ClearSight system from Edwards Lifesciences is a non-invasive medical system that allows continuous monitoring of blood pressure (cBP), as well as a range of other hemodynamic parameters such as cardiac output (CO), stroke volume (SV), and systemic vascular resistance (SVR).

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 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • adult parturients, singleton gestation, elective cesarean section

排除标准

  • ASA >II, age <18 years, Body Mass Index (BMI) >40 kg/m2, body weight <50 kg, body weight>100 kg, height<150 cm, height>180 cm, multiple gestation, fetal abnormality, fetal distress, active labor, emergency CT, cardiovascular disease or cerebrovascular disease, pre-existing or pregnancy-induced hypertension, use of antihypertensive medication during pregnancy, preeclampsia, any contraindication for regional anesthesia, such as thrombocytopenia or coagulation disorder, communication or language barriers, lack of informed consent

研究组 & 干预措施

Metaraminol group

Active Comparator

干预措施: Metaraminol infusion (Procedure)

Norepinephrine group

Active Comparator

干预措施: Norepinephrine infusion (Procedure)

结局指标

主要结局

incidence of hypotension

时间窗: intraoperative

any occurrence of hypotension throughout the operation will be recorded (SAP \< 80% of baseline)

number of hypotensive episodes in the pregnant woman

时间窗: intraoperativre

the number of hypotensive episodes (SAP \< 80% of baseline)throughout the operation will be recorded

incidence of bradycardia

时间窗: intraoperative

any incidence of HR \< 60/min will be recorded

次要结局

  • need for vasoconstrictor(intraoperative)
  • type of bolus vasopressor administered(intraoperative)
  • number of bolus doses of vasoconstrictor administered(intraoperative)
  • total dose of vasoconstrictor administered(intraoperative)
  • need for administration of atropine(intraoperative)
  • incidence of hypertension(intraoperative)
  • need for differentiation in the basic infusion rate of the vasopressor solution(intraoperative)
  • incidence of nausea/vomiting(intraoperative)
  • Incidence of dizziness, discomfort, and shivering(intraoperative)
  • neonatal Apgar score(1 min and 5 min post delivery)
  • neonatal blood gases(1 min post delivery)
  • glucose in neonatal blood(1 min post delivery)

研究者

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

Adamantia Gkaniou

Resident anaesthesiologist, MD, MSc

Aretaieion University Hospital

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