Preload Optimization Guided by Inferior Vena Cava Collapsibility Index in Parturients With Prophylactic Norepinephrine Infusion Undergoing Cesarean Section: a Randomized, Dose-finding Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
研究概览
简要总结
The purpose of this study is to investigate the optimal preload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.
详细描述
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the investigator's study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of preload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-40 years
- •Primipara or multipara
- •Singleton pregnancy ≥37 weeks
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for elective cesarean section under spinal anesthesia
排除标准
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
- •Hemoglobin < 7g/dl
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Control group
No preload was given before spinal anesthesia
干预措施: Control group (Drug)
4 ml/kg group
4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia
干预措施: 4 ml/kg group. (Drug)
8 ml/kg group
8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
干预措施: 8 ml/kg group. (Drug)
12 ml/kg group
12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
干预措施: 12 ml/kg group. (Drug)
结局指标
主要结局
The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)
时间窗: Before leaving the operating room
IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]
次要结局
- The incidence of post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia)
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia.)
- pH(Immediately after delivery)
- Overall stability of heart rate control versus baseline(1-15 minutes after spinal anesthesia.)
- Base excess(Immediately after delivery)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia.)
- The incidence of hypertension(1-15 minutes after spinal anesthesia)
- Partial pressure of oxygen(Immediately after delivery)
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia.)
- The incidence of bradycardia(1-15 minutes after spinal anesthesia)
- APGAR score(5min after delivery)