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临床试验/NCT02432781
NCT02432781已完成不适用

Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery in DM Patients Undergoing Total Knee Arthroplasty

Severance Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2015年6月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Incidence of postoperative nausea and vomiting

研究概览

简要总结

The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty. The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.

详细描述

Carbohydrate-rich drink has been proved to neither delay gastric emptying nor affect gastric acidity and is therefore considered safe to use in elective surgical patients without risk factors for pulmonary aspiration. It reduced postoperative nausea and vomiting and improved sense of well-being after surgery. Moreover, carbohydrate-rich drink was not found to be affected by delayed gastric emptying in patients with uncomplicated type 2 diabetes. Therefore, carbohydrate drink may be safely administered 3 h before anesthesia without risk of hyperglycemia or aspiration.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Type 2 DM patients undergoing elective total knee arthroplasty

排除标准

  • Contraindication to regional anesthesia
  • Patients whose operation is scheduled to start after 9:00 am
  • Dementia or cognitive dysfunction
  • HbA1c > 8%
  • Gastroesophageal reflux disease

研究组 & 干预措施

Carbohydrate group

Experimental

Carbohydrate-rich drink 400 mL 3 h before surgery

干预措施: Carbohydrate-rich drink (Dietary Supplement)

Control group

Active Comparator

10% dextrose solution mixed with insulin 16 unit 100 mL/h

干预措施: 10% dextrose solution mixed with insulin 16 unit 100 mL/h (Dietary Supplement)

结局指标

主要结局

Incidence of postoperative nausea and vomiting

时间窗: 24 hours

次要结局

  • Score of quality of recovery(24 hours)
  • Degree of inflammation(24 hours)

研究者

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

So Yeon Kim

Assistant professor

Severance Hospital

研究点 (1)

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