The Effectiveness of Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Insulin Resistance
研究概览
简要总结
It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery
详细描述
The tsudy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Only assessor are blinded to the masking. Participants are asked for consent to receive the intervention
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA Physical Status I and II
- •Able to tolerate enteral feeding
- •Subjects are undergoing surgery with general anesthesia
排除标准
- •Subjects consume corticosteroids and insulin
- •Subjects have endocrine disorder, gastroesophageal reflux disease and psychiatric disorder
- •Subjects are treated with preoperative parenteral nutrition
- •The surgical procedure is longer than 4 hours
- •Drop out Criteria:
- •- Intraoperative surgical emergency e.g. massive bleeding
研究组 & 干预措施
Placebo
Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight
干预措施: Water (Placebo) (Other)
Carbohydrate loading
Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight
干预措施: Carbohydrate loading (Other)
结局指标
主要结局
Insulin Resistance
时间窗: measured just before incision and 24 hour after surgery
Insulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5
次要结局
未报告次要终点
研究者
Yunita Widyastuti
Professor in Pediatric Anesthesia
Gadjah Mada University