NCT03729076已完成不适用
Crystalloid Versus Colloid Rapid Co-load in Parturients Receiving Prophylactic Phenylephrine Infusion During Cesarean Delivery Under Spinal Anesthesia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of maternal hypotension
研究概览
简要总结
The study aims to compare crystalloid co-loading and colloid co-loading in parturients receiving prophylactic phenylephrine infusion during cesarean delivery in terms of the incidence of hypotension.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, full-term parturients who scheduled to undergo elective cesarean delivery under spinal anesthesia.
排除标准
- •multiple pregnancy
- •gestational age < 36 weeks
- •preexisting or pregnancy-induced hypertension
- •Morbid cardiovascular impairments
- •Cerebrovascular disease
- •⑥ Known fetal anomaly
- •⑦ Contraindications to spinal anesthesia
- •⑧ Any sign of onset of labor
- •⑨ Body weight < 45 kg or body weight > 90 kg
- •⑩ Height < 145cm or height > 180cm
结局指标
主要结局
Incidence of maternal hypotension
时间窗: during the time period from induction of spinal anesthesia until delivery
defined as: Systolic Blood Pressure (SBP) \< 80% of baseline SBP
次要结局
- incidence of symptomatic hypotension(during the time period from induction of spinal anesthesia until delivery)
- incidence of severe hypotension(during the time period from induction of spinal anesthesia until delivery)
- incidence of bradycardia(during the time period from induction of spinal anesthesia until delivery)
- incidence of Hypertension(during the time period from induction of spinal anesthesia until delivery)
- Cumulative duration of hypotension(during the time period from induction of spinal anesthesia until delivery)
- Onset time of hypotension(during the time period from induction of spinal anesthesia until delivery)
- Rescue phenylephrine use(during the time period from induction of spinal anesthesia until delivery)
- Apgar Score, 1 min, 5 min (fetal outcome)(1 min, 5 min after delivery)
- Umbilical arterial base excess(immediately after delivery)
- Cutaneous stellate ganglion sympathetic activity(during the time period from induction of spinal anesthesia until delivery)
- Minimum recorded Systolic Blood Pressure (Minimum SBP)(during the time period from induction of spinal anesthesia until delivery)
- Rescue ephedrine use(during the time period from induction of spinal anesthesia until delivery)
- Incidence of nausea, vomiting(during the time period from induction of spinal anesthesia until delivery)
- Incidence of dizziness, breathlessness(during the time period from induction of spinal anesthesia until delivery)
- Minimum recorded Heart Rate (Minimum HR)(during the time period from induction of spinal anesthesia until delivery)
- Total phenylephrine use(during the time period from induction of spinal anesthesia until delivery)
- Atropine use(during the time period from induction of spinal anesthesia until delivery)
- Umbilical arterial pH(immediately after delivery)
- Umbilical arterial partial oxygen pressure (PO2)(immediately after delivery)
- Umbilical arterial carbon dioxide partial pressure (PCO2)(immediately after delivery)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital
研究点 (1)
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