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临床试验/NCT03842527
NCT03842527已完成不适用

Pre-Operative Gastric Volume Assessment Following Carbohydrate-Loading in Obstetrical Patients Undergoing Elective Cesarean Section: A Randomized Clinical Pilot Study

University of Calgary4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
4
主要终点
Incidence of Grade 2 antrum

研究概览

简要总结

In recent years, human and animal studies have found that carbohydrate-loading prior to surgery leads to improved response to surgical stress and improved postoperative well-being when compared to traditional fasting guidelines. Such positive findings have lead to the increased use of preoperative intake of carbohydrate rich drinks prior to elective surgeries.

However, one of the biggest risks during surgery when a patient is asleep is having stomach contents come up into the lungs. For this reason, a stomach that is empty or has minimal amount of contents is safest. Historically, patients have been instructed not to eat or drink for 8 hours before surgery because it was thought to lower the risk of having fluid or contents in the stomach. This is the current practice patients are asked to follow before undergoing a C-section. However, non-pregnant patients undergoing other surgeries are instructed to have carbohydrate-rich drinks because of the potential benefits. Using ultrasound, the abdomen can be simply scanned to see if there are stomach contents present before surgery. This can allow for the potential determination of what the aspiration risk may be.

What the investigators want to do is look at the safety of using carbohydrate-loading in patients having a C-section. The investigators want to make sure that patients who follow carbohydrate-loading by having a clear, sugary drink 3 hours before a C-section are not at greater risk of having a large amount of stomach contents and be at higher risk of aspirating. This will be done by taking an ultrasound scan of the stomach that will tell the investigators if there are contents in the stomach and whether there is a risk of aspiration.

Patients having an elective C-section will be randomized into two groups. The first group will follow carbohydrate-loading by having a drink of apple juice or cranberry juice cocktail the night before (800mL) and 3 hours before (400mL) the C-section. The second group will follow standard practice of not eating or drinking less than 8 hours prior to surgery. An anesthesiologist will ultrasound the stomach 1 hour before the scheduled procedure time. The first ultrasound will be completed in the supine position (lying on back). The second will be done in the right lateral decubitus position (lying on right side). This should not take more than 5-10 minutes total.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-laboring pregnant women
  • ≥36 weeks gestational age
  • scheduled elective cesarean delivery
  • ≥18 years of age
  • ASA physical status I to III
  • weight 50 to 120 kg
  • height ≥150 cm
  • Ability to understand the rationale of the study assessments

排除标准

  • multiple gestation
  • abnormal anatomy of the upper gastrointestinal tract
  • gestational diabetes or pre-existing diabetes mellitus
  • previous surgical procedures on the esophagus, stomach, or upper abdomen

结局指标

主要结局

Incidence of Grade 2 antrum

时间窗: 1 hour prior to C-section delivery

Clear fluid is evident in antrum in both supine and right lateral decubitus scanning positions

次要结局

  • Incidence of Grade 0 antrum(1 hour prior to C-section)
  • Incidence of Grade 1 antrum(1 hour prior to C-section)
  • Cross-sectional antral area(1 hour prior to C-section)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Hurdle

Anesthesiologist, Clinical Assistant Professor, Department of Anesthesiology, Perioperative and Pain Medicine

University of Calgary

研究点 (4)

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