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临床试验/NCT02706522
NCT02706522已完成不适用

Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients

Gangnam Severance Hospital0 个研究点目标入组 3 人开始时间: 2016年10月24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
3
主要终点
serum S-100β level

研究概览

简要总结

This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.

详细描述

Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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 undergoing total hip replacement or total knee replacement surgery

排除标准

  • Gastro-esophageal reflux
  • Upper gastrointestinal motility disorder
  • Inflammatory bowel disease
  • Intraperitoneal malignancy history
  • Inability to perform cognitive function test

研究组 & 干预措施

Allocated to Carbohydrated group

Experimental
  1. Patients was administered in hospital
  2. Randomization
  3. Patient was allocated to Carbohydrated group
  4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

干预措施: Allocated to Carbohydrated group (Dietary Supplement)

Allocated to Placebo group

Placebo Comparator
  1. Patients was administered in hospital
  2. Randomization
  3. Patient was allocated to Placebo group
  4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.

干预措施: Allocated to Placebo group (Dietary Supplement)

结局指标

主要结局

serum S-100β level

时间窗: Postoperative 1 hr

次要结局

未报告次要终点

研究者

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

SeHee Na

Associate Professor MD

Gangnam Severance Hospital

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