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临床试验/NCT05035485
NCT05035485已完成不适用

Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses During Spinal Anesthesia for Caesarean Section in Patients With Severe Preeclampsia: a Randomized, Controlled Trial

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月13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
已完成
发起方
入组人数
40
试验地点
1
主要终点
Systemic vascular resistance (SVR)

研究概览

简要总结

The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

详细描述

Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

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
Double (Participant, Care Provider)

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

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥32 weeks
  • American Society of Anesthesiologists physical status classification II to III
  • Scheduled for cesarean section under spinal anesthesia

排除标准

  • Baseline blood pressure ≥180 mmHg
  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

研究组 & 干预措施

Phenylephrine group

Active Comparator

Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred

干预措施: Phenylephrine (Drug)

Norepinephrine group

Experimental

Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Systemic vascular resistance (SVR)

时间窗: 1-30 minutes after spinal anesthesia

Evaluated by the VIGILCO monitoring system.

Cardiac output (CO)

时间窗: 1-30 minutes after spinal anesthesia.

Evaluated by the VIGILCO monitoring system.

Stroke volume (SV)

时间窗: 1-30 minutes after spinal anesthesia

Evaluated by the VIGILCO monitoring system.

次要结局

  • The incidence of nausea and vomiting.(1-30 minutes after spinal anesthesia)
  • APGAR score(5 min after delivery)
  • Partial pressure of oxygen (PO2)(Immediately after delivery)
  • Overall stability of heart rate control versus baseline(1-30 minutes after spinal anesthesia)
  • The incidence of hypertension.(1-30 minutes after spinal anesthesia)
  • The incidence of bradycardia.(1-30 minutes after spinal anesthesia)
  • Overall stability of systolic blood pressure control versus baseline(1-30 minutes after spinal anesthesia)
  • The incidence of post-spinal anesthesia hypotension(1-30 minutes after spinal anesthesia.)
  • The incidence of severe post-spinal anesthesia hypotension.(1-30 minutes after spinal anesthesia.)
  • pH(Immediately after delivery)
  • Base excess (BE)(Immediately after delivery)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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