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临床试验/NCT05406245
NCT05406245Unknown不适用

The Effect of Stress on the Residual Gastric Volume in Older Adults Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
53
试验地点
1
主要终点
Level of stress hormone 1

研究概览

简要总结

In our institution, many patients undergo staged bilateral total knee arthroplasty at weekly intervals, and most of the patients are older adults with degenerative arthritis. As recommended, the older adult patients who undergoing total knee arthroplasty drink carbohydrate-containing fluid (400 ml) 2 hours prior to surgery. In this type of surgery, there are additional points to consider when applying the fasting guidelines. This is because, in addition to the factor of advanced age, which can affect gastric emptying time, the patient's physical, medical, and psychological conditions at the first and the second operation may be different. For example, the effect of the acute pain that occurs after the first total knee arthroplasty and subsequent opioids administered on gastric motility cannot be ignored. However, to date, there have been no studies examining the association of stress (emotional and surgical) and residual gastric volume of older adult patients with staged bilateral total knee arthroplasty and whether there is a difference according to the stage when carbohydrate-containing fluid is ingested.

In the present study, the investigators will evaluate the effect of emotional stress, surgical stress, pain, and the use of opioids on the residual gastric volume in older adults undergoing staged-bilateral total knee arthroplasty.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for staged bilateral total knee arthroplasty aged ≥ 65
  • American Society of Anesthesiologists physical status classification 1, 2, and 3
  • Body mass index < 35 kg/cm2
  • Patients administered carbohydrate-containing fluid 2 hours prior to surgery

排除标准

  • Previous surgery of the upper gastrointestinal tract
  • Achalasia

结局指标

主要结局

Level of stress hormone 1

时间窗: After induction of spinal anesthesia at first stage total knee arthroplasty/ an average 10 minutes

Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia

Level of stress hormone 2

时间窗: After induction of spinal anesthesia at second stage total knee arthroplasty/ an average 10 minutes

Stress hormone (interleukin-1β, interleukin-6, interleukin-10, and tumor necrosis factor-α) measured after induction of spinal anesthesia

次要结局

  • Gastric volume 1(First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes)
  • Gastric volume 2(Second stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes)
  • Anxiety scale 2(Second stage operation, one day before surgery/ an average of 30 minutes)
  • Anxiety scale 1(First stage operation, one day before surgery/ an average of 30 minutes)

研究者

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

Hyo-Seok Na

Professor

Seoul National University Bundang Hospital

研究点 (1)

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