Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of hypotension events with treatment related
研究概览
简要总结
The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant woman scheduled for elective cesarean delivery under spinal anesthesia
排除标准
- •patients who refuse involved
- •patients who have pre-eclampsia
- •patients who have heart disease
- •patients who fetal distress is suspicious
研究组 & 干预措施
"BUPI","P"
patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
干预措施: Bupivacaine (Drug)
"BUPI","P"
patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
干预措施: Phenylephrine (Drug)
"BUPI","N"
patients who received hyperbaric bupivacaine and continous infusion of normal saline
干预措施: Bupivacaine (Drug)
"BUPI","N"
patients who received hyperbaric bupivacaine and continous infusion of normal saline
干预措施: normal saline (Drug)
"LEVO","P"
patients who received isobaric levobupivacaine and continous infusion of phenylephrine
干预措施: Levobupivacaine (Drug)
"LEVO","P"
patients who received isobaric levobupivacaine and continous infusion of phenylephrine
干预措施: Phenylephrine (Drug)
"LEVO","N"
patients who received isobaric levobupivacaine and continous infusion of normal saline
干预措施: Levobupivacaine (Drug)
"LEVO","N"
patients who received isobaric levobupivacaine and continous infusion of normal saline
干预措施: normal saline (Drug)
结局指标
主要结局
Number of hypotension events with treatment related
时间窗: during 30min after spinal anesthesia
blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome.
次要结局
- total dose of phenylephrine(during the surgery)
研究者
Jae-Hyon Bahk, MD, PhD
Professor
Seoul National University Hospital