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临床试验/NCT02330263
NCT02330263已完成不适用

Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)

Yonsei University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2015年1月1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
57
试验地点
1
主要终点
postoperative insulin resistance

研究概览

简要总结

Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who are scheduled to undergo OPCAB

排除标准

  • •Subjects are ineligible if they have DM(Diabetes Mellitus),
  • •Gastroesophageal reflux disease or gastric emptying disorder,
  • •inflammatory bowel disease,
  • •previous treatment for intra-abdominal cancer,
  • •entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
  • •cognitive dysfunction,
  • •disabling mental change disorder,
  • •are unable to communicate or speak Korean

研究组 & 干预措施

carbohydrate group

Experimental

Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before their surgery and in the morning of the operation day (3 hours before their scheduled operation).

干预措施: carbohydrate beverage (Dietary Supplement)

control group

No Intervention

Patients in the control group consume no food or drink after midnight before surgery.

结局指标

主要结局

postoperative insulin resistance

时间窗: within 1 hour after surgery

次要结局

  • preoperative discomfort(24 hours)
  • perioperative hemodynamic effect(24 hours)
  • postoperative complications(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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