Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index During Cesarean Delivery: a Randomized Double Blinded Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- The incidence of hypotension
研究概览
简要总结
The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility index (IVC-CI).
详细描述
Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal hypotension. Norepinephrine is new vasopressor that has been suggested as a potential alternative to phenylephrine and was recently introduced in obstetric anesthesia because of the minimal cardiac depressant effect. The purpose of this study is to investigate the preventive effect of norepinephrine on post-spinal hypotension and the effect on inferior vena cava collapsibility index (IVC-CI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-45 years
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for elective cesarean delivery under spinal anesthesia
- •Full-term, singleton, pregnant women
排除标准
- •Height of no more than 150 centimeters
- •Body weight greater than 100 kg or BMI greater than 30
- •Labor analgesia had been performed
- •Contraindication of spinal or epidural anesthesia
- •Eclampsia or chronic hypertension or baseline blood pressure ≥160mmHg
- •Hemoglobin <7g/dl
- •Fetal distress or known abnormal fetal development
- •Severe vascular disease
- •Diabetes mellitus or cardiovascular disease or nervous system disease
研究组 & 干预措施
Norepinephrine
Simultaneous with subarachnoid block, a bolus of norepinephrine was given followed by norepinephrine infusion
干预措施: Norepinephrine (Drug)
Normal saline
Simultaneous with subarachnoid block, a bolus of normal saline was given followed by normal saline infusion
干预措施: normal saline (Drug)
结局指标
主要结局
The incidence of hypotension
时间窗: 1 to 20 minutes after subarachnoid block
SBP decreased to \<80% of the baseline value
Inferior vena cava collapsibility index
时间窗: 5 to 20 minutes after subarachnoid block
CI = (dIVCmax - dIVCmin)/dIVCmax
次要结局
- Arterial base excess of fetal vein blood(Immediately after delivery)
- Incidence of hypertension(1 to 20 minutes after subarachnoid block)
- Number of rescue norepinephrine(Immediately to 20 minutes after subarachnoid block)
- APGAR score(10min after delivery)
- The incidence of nausea and vomiting(1 to 20 minutes after subarachnoid block)
- The incidence of bradycardia(1 to 20 minutes after subarachnoid block)
- Pressure of oxygen of fetal vein blood(Immediately after delivery)
- pH value of fetal vein blood(Immediately after delivery)