Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance, Tramadol PCA and Early Postoperative Enteral Nutrition in Patients After Gastrointestinal Laparoscopic Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
研究概览
简要总结
It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.
Postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response.
The main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PCA,parecoxib,placebo
PCA for 2 days after operation, i.v parecoxib in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery
干预措施: parecoxib (Drug)
PCA,parecoxib,celecoxib
PCA for 2 days after operation,i.v parecoxib in 2 days after surgery and oral celecoxib in the day 3 to day 5 after surgery
干预措施: parecoxib (Drug)
结局指标
主要结局
Insulin resistance in perioperative period of gastrointestinal laparoscopic surgery
时间窗: 5 days after operation
次要结局
- Pain intensity at rest and during leg raising recorded daily after surgery using Visible Numeric Rating Scale(5 days after operation)
- Incidence of adverse events throughout the treatment period including nausea, vomiting, headache, urinary retention, somnolence, flatulence, and pruritus(5 days after operation or more)
- Liver and renal function tests in perioperative period(5 days after operation)
- Self-rating anxiety scale and self-rating questionnaire for depression before surgery(1 day before surgery)
- The consumption of total and incremental tramadol after surgery.(5 days after operation)
- The tolerated dose of enteral nutrition every day after surgery(5 days after operation)
- Postoperative inflammatory factors (IL-4, IL-6 and TNF-α) and levels of stress hormone (glucocorticoids and catecholamines) in perioperative period of gastrointestinal laparoscopic surgery(5 days after operation)
- Rest energy metabolism was measured in perioperative period to evaluate the caloric and substrate needs of our patients(5 days after operation)
- The time of the first bowel movements and anal exhaust time after surgery(5 days after operation or more)
研究者
Kong Wencheng
Senior Resident
Jinling Hospital, China