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临床试验/NCT04815070
NCT04815070
已完成
不适用

Comparison of Fasting Gastric Volume Using Ultrasound in Diabetic and Non-Diabetic Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty: A Prospective Observational Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 40 人2021年3月29日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Degenerative Arthritis
发起方
Seoul National University Bundang Hospital
入组人数
40
试验地点
1
主要终点
Volume of Gastric Contents
状态
已完成
最后更新
3年前

概览

简要总结

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.

In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.

注册库
clinicaltrials.gov
开始日期
2021年3月29日
结束日期
2022年3月7日
最后更新
3年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Hyo-Seok Na

Professor

Seoul National University Bundang Hospital

入排标准

入选标准

  • Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
  • American Society of Anestheiologist physical status classification 1, 2, and 3
  • Body mass index \< 35 kg/cm2

排除标准

  • Previous surgery of the upper gastrointestinal tract
  • Achalasia

结局指标

主要结局

Volume of Gastric Contents

时间窗: Less than one hour prior to surgery

A "full stomach" is defined as on containing a) solid or thick fluid content or b) 1.5 mL/kg of clear fluid.

次要结局

  • Numerical rating pain scale(One hour prior to surgery, Postoperative 24 and 48 hour)
  • Rescue analgesics(Postoperative 24 and 48 hour)

研究点 (1)

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