Comparison of Gastric Emptying of Water in Obese vs. Non-obese Term Pregnant Women Undergoing Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Gastric antral cross-sectional area
研究概览
简要总结
It has been believed that the risk of pulmonary aspiration in term pregnant women is increased, and should be considered that all term pregnant women to have "full stomach". Recently, gastric ultrasound has been adopted as a useful tool for quantitative and qualitative assessment of stomach before anesthesia, and predict the risk of pulmonary aspiration.
Although, both the obesity and pregnancy are known to be the risk of pulmonary aspiration, it is suggested in the American Society of Anesthesiology fasting guidelines, that the same fasting time should be applied in the obese and non-obese parturients. However, this was based on one study done in a small (10) numbers of volunteers.
Therefore, the investigators aimed to compare the gastric antral cross-sectional area in both obese and non-obese term pregnant women, scheduled for elective cesarean section.
详细描述
This study is a prospective, observational study. 42 term (≥37 weeks) pregnant, non-laboring adult women scheduled for cesarean delivery will be included in the study. They will be allowed to drink water freely, until 2 hours before the anesthesia. Gastric ultrasound will be performed in 21 non-obese women, and 21 obese women. The obesity is defined by the body mass index at term.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non laboring, term (≥37 weeks) pregnant women
- •Scheduled for elective cesarean section
- •aged ≥ 18 years old
- •American Society of Anesthesiology physical class 1-3
排除标准
- •multigestational pregnancy
- •diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
结局指标
主要结局
Gastric antral cross-sectional area
时间窗: 2 hours after the time allowed to drink water.
Cross-sectional area of gastric antrum assessed by ultrasonography
次要结局
- Hunger score(2 hours after the time allowed to drink water.)
- Preoperative anxiety(2 hours after the time allowed to drink water.)
- Thirst score(2 hours after the time allowed to drink water.)
研究者
Eunah Cho, MD
Clinical Assistant Professor
Kangbuk Samsung Hospital