Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose of morphine administered during the postoperative period (patient controlled analgesia)
研究概览
简要总结
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Patients scheduled for an abdominal surgery
排除标准
- •Age less than 18 years,
- •Pregnant women,
- •Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
- •Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- •Inflammatory bowel disease,
- •Chronic pain,
- •Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- •Alcoholic patients and patients taking opiates,
- •History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
- •Emergency surgery
研究组 & 干预措施
1
Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
干预措施: Remifentanil (Drug)
2
Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria
干预措施: Sufentanil (Drug)
结局指标
主要结局
Dose of morphine administered during the postoperative period (patient controlled analgesia)
时间窗: 48 postoperative hours
次要结局
- postoperative pain scores(48 postoperative hours)
- postoperative hyperalgesia(up to 5th to 7th postoperative days)
- nausea vomiting(48 postoperative hours)