NCT02737813已完成4 期
Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change of cardiac output (L/min) after spinal block
研究概览
简要总结
Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology classification I - II
- •Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
- •Singleton pregnancy
- •Body mass index < 40 kg/m2
排除标准
- •Pregnancy <35 weeks gestational age
- •Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
- •History of allergy to the study drugs
研究组 & 干预措施
Isobaric Marcaine
Experimental
Isobaric Marcaine 2.2 mL for spinal block
干预措施: Isobaric marcaine (Drug)
Hyperbaric Marcaine
Active Comparator
Hyperbaric Marcaine 2.2 mL for spinal block
干预措施: Hyperbaric marcaine (Drug)
结局指标
主要结局
Change of cardiac output (L/min) after spinal block
时间窗: 5 minutes after spinal block
The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.
次要结局
- Total dose of vasopressor(2 hours)
- Number of patients who experience systolic blood pressure < 25% of preoperative measurement(2 hours)
研究者
Sirilak Suksompong
Associate Professor
Mahidol University
研究点 (1)
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