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临床试验/NCT04206189
NCT04206189已完成不适用

Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients

Yonsei University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年4月1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
56
试验地点
1
主要终点
Insulin resistance

研究概览

简要总结

Postoperative cognitive dysfunction (POCD) is more common in older patients, and increased insulin resistance is an important factor for POCD. Fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. However, prolonged fasting increases insulin resistance. Recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. Therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. Fifty patients (age>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 h before surgery according to standard protocol.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Investigator and outcomes assessor are blinded to group assignment.

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 arthroplasty
  • age>65 years

排除标准

  • The subject is a foreigner or illiterate
  • Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
  • Patients with chronic renal disease or severe cardiovascular disease
  • HbA1c >69 mmol/mol or BMI >30 kg/m2
  • A duration of ≥5 h between consumption of CHO and initiation of surgery.

结局指标

主要结局

Insulin resistance

时间窗: 1 hour after surgery

Insulin resistance index = glucose x insulin/22.5

次要结局

  • glycemic variability(10 minutes after admission of recovery room)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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