Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
研究概览
简要总结
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.
详细描述
To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
the outcome accessor and care provider will be aware in which gropu the patient was
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant 37-41 weeks
- •one fetus
- •scheduled for C/S under spinal anesthesia
- •accepting to participate
排除标准
- •Emergency surgery
- •placenta previa
- •preeclampsia
- •cardiovascular and cerebrovascular comorbidities
- •morbid obesity (BMI>40)
- •pregnancy weeks <36 and > 41
- •The use of vasoconstrictors
- •Severe Anemia ( Hb <9 g/dl)
- •Refusal or known contraindication for spinal anesthesia
结局指标
主要结局
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
时间窗: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.
Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed.
次要结局
未报告次要终点
研究者
hafize fisun demir
Assistant Professor
Balikesir University