Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Quality of Recovery score using the QoR-40 Questionnaire
研究概览
简要总结
Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laparoscopic cholecystectomy.
- •KAROFSKY PERFORMANCE SCALE >70,
- •No history of major operation
排除标准
- •DM patients
- •GE reflux Hx patients.
- •No- compliance,
- •Previous Abdominal Surgery History
研究组 & 干预措施
Allocated to MN NPO group,
- Patients was administered in hospital
- Randomization
- Patient was allocated to MN group
- Patients were NPO from mid night (MN) to Surgery
干预措施: Allocated to MN NPO group, (Dietary Supplement)
Allocated to Placebo group
- Patients was administered in hospital
- Randomization
- Patient was allocated to Placebo group
- 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)
Allocated to Carbohydrated group
- Patients was administered in hospital
- Randomization
- Patient was allocated to Carbohydrated group
- 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)
结局指标
主要结局
Quality of Recovery score using the QoR-40 Questionnaire
时间窗: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days
We check the QoR-40 Questionnaire at discharge day
次要结局
未报告次要终点
研究者
Joon Seong Park
GangNam Severance Hospital
Yonsei University