Effect of Epidural Anesthesia and Analgesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity
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
- Hyperinsulinemic-euglycemic clamp
研究概览
简要总结
Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is unclear, however, whether the preoperative metabolic status of the surgical patient plays a role in the degree of this hyperglycemic response. For instance, the presence of low insulin sensitivity before surgery could predispose the individual to an altered metabolic response after surgery. In this case, it would be appropriate to identify adequate interventions that attenuate the response to surgical stress and facilitate the recovery process.
The aims of this research projects are the following:
- To determine the extent in which epidural local anesthetics, initiated before surgery and continued after surgery, improves insulin secretion in patients with preoperative low insulin sensitivity.
- To understand which measures of postoperative recovery are sensitive to the restoration of insulin secretion in this particular group of patients
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving elective resection of malignant, non metastatic, colorectal lesions
排除标准
- •American Society of Anesthesiologists (ASA) health status class 4-5
- •Dementia,neuromuscular disease, psychosis
- •Cardiac abnormalities
- •Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)
- •Chronic obstructive pulmonary disease
- •Renal failure (creatinine > 1.5 mg/dl)
- •Hepatic failure (liver transaminases >50% over the normal range)
- •Diabetics with glycosylated hemoglobin > 6%
- •Steroid consumption longer than 30 days sepsis
- •Morbid obesity (body mass index >40)
- •Anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl).
- •Patients will be excluded if they have poor English or French comprehension.
研究组 & 干预措施
General Anesthesia
Patients will receive general anesthesia alone followed by intravenous morphine for postoperative pain control. This techniques is safe and is standard procedure for colorectal surgery.
干预措施: Anesthesia (Procedure)
Epidural Anesthesia
Patients will receive general anesthesia plus epidural anesthesia followed by epidural analgesia for postoperative pain control. This techniques is safe and standard procedure for colorectal surgery.
干预措施: Anesthesia (Procedure)
结局指标
主要结局
Hyperinsulinemic-euglycemic clamp
时间窗: up to 2 days after surgery
The Hyperinsulinemic-euglycemic clamp is the gold standard for measuring insulin sensitivity. Patients receive a 2 hour infusion of glucose and insulin, which is adjusted throughout the study period in order to maintain a blood glucose concentration at 5.5mmol/L. The test will take place one week before surgery and on the second postoperative day.
次要结局
未报告次要终点
研究者
Gabriele Baldini, MD, MSc, Assistant Professor
Assitant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre