Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- amount of remifentanil delivered by the closed-loop system
研究概览
简要总结
The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications.
The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller.
Two groups of patients are compared:
- one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening,
- one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml).
In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.
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
- Triple (Participant, Care Provider, Investigator)
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 undergoing a thoracotomy under general anesthesia and epidural anesthesia
排除标准
- •age lower than 18 years,
- •pregnant woman,
- •psychotropic treatment,
- •central neurological disorder or lesion cerebral,
- •allergy to propofol or to a muscle relaxant,
- •refusal or contra-indication of epidural anesthesia,
- •severe emphysema,
- •coronary disease,
- •treatment with a beta-blocker or a vasoactive drug.
研究组 & 干预措施
1
general anesthesia and thoracic epidural administration of saline
干预措施: remifentanil (Drug)
2
general anesthesia and thoracic epidural administration of chirocaine
干预措施: remifentanil (Drug)
结局指标
主要结局
amount of remifentanil delivered by the closed-loop system
时间窗: end of anesthesia
次要结局
- amount of propofol delivered by the closed-loop system(end of anesthesia)