Impact of Pre-operative Carbohydrate Drink Provision on Attenuating Peri-operative Insulin Resistant in Major Abdominal Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- difference in insulin resistance
研究概览
简要总结
Enhanced Recovery after Surgery (ERAS) pathways include multiple evidence-based interventions delivered throughout the peri-operative period that aim to attenuate the surgical stress response and support rapid physiologic and functional recovery.A key element of the ERAS pathway is the administration of a clear carbohydrate-rich beverage 2-3 h before surgery in order to keep the patient in a fed state rather than a fasted state when they go to the operating room. The aim of the current study is to investigate the impact of a drink containing simple carbohydrate on attenuating surgical stress induced insulin resistance in patients undergoing major laparoscopic abdominal surgery, compared to drinks containing maltodextrin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Planned laparoscopic partial colon resection for non-metastatic neoplastic or benign disease (including right, transverse, left or sigmoid))
- •HbA1c less than or equal to 5.7%
- •Not receiving any kind of glucose lowering medication.
排除标准
- •Are already diagnosed with diabetes or pre diabetes (HbA1c > 5.7%)
- •Are pre-diabetic receiving glucose lowering intervention (any glucose lowering medication)
- •Have renal or liver dysfunction (serum creatinine above 1.4 mg/dL in women and 1.5 mg/dL in men, bilirubin >2.9 mg/dL)
- •Will undergo extended resection of adjacent organs
- •Non-elective operations
- •New stoma created
- •Have conditions precluding participation in the ERAS pathway (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
- •Have conditions requiring preoperative fasting: documented gastroparesis, patient on metoclopramide and/or domperidone, achalasia, dysphagia (any difficulty with swallowing), or Fluid restriction (e.g. dialysis, pulmonary oedema, congestive heart failure).
- •Have cardiac abnormalities, severe end-organ disease such as cardiac failure (New York Heart Association classes III-IV), chronic obstructive pulmonary disease (documented by abnormal pulmonary function test), morbid obesity (BMI >40 kg/m2), anemia (hematocrit < 30 %, hemoglobin <100g/L, albumin < 25mg/dl)
- •Have received steroids for longer than 30 days
- •Have poor English or French comprehension.
研究组 & 干预措施
simple carbohydrate drink
Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.
干预措施: simple carbohydrate drink (Dietary Supplement)
complex carbohydrate drink
Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery.
干预措施: complex carbohydrate drink (Dietary Supplement)
结局指标
主要结局
difference in insulin resistance
时间窗: Intra-operative from beginning of surgical procedure until the end of the procedure
intra-operative insulin resistance as assessed by glucose infusion rate required to maintain euglycemic state during a hyperinsulinemic euglycemic glucose clamp
次要结局
- Comparing the Homeostasis model assessment (HOMA) index at four different time points ( by employing Fasting blood sugar and Plasma Insulin)(at 4 time points as follow : on the morning before surgery, first, second and third morning after the surgery)
- Comparing the preoperative thirst(Two times at 2 weeks before surgery (baseline) and immediately before surgery)
- Comparing the preoperative hunger(Two times at 2 weeks before surgery (baseline) and immediately before surgery)
- Comparing the preoperative well-being(Two times at 2 weeks before surgery (baseline) and immediately before surgery)
- Comparing the preoperative anxiety(Two times at 2 weeks before surgery (baseline) and immediately before surgery)
- Grip strength(Two times at 2 weeks before surgery (baseline) and 2 days after surgery)
- Time to readiness for discharge (TRD)(up to 30 days after surgery)
- Postoperative infectious complications(30 days after operation)
研究者
Dr. Liane S. Feldman
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre