Anesthésie Totale Intraveineuse en " Boucle d'Asservissement " guidée Par l'Index Bispectral : Effet de l'Adjonction de Protoxyde d'Azote (Effect of Nitrous Oxide on Intravenous Closed-loop Anesthesia)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 672
- 试验地点
- 17
- 主要终点
- Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.
研究概览
简要总结
The main objective of the study is to analyze the influence of nitrous oxide on propofol and remifentanil requirements.
详细描述
Nitrous oxide is a widely used anesthetic agent. The mechanism of its central action is not completely understood and its importance is questioned.
Total intravenous anesthesia can be driven by a computer using bispectral index as a controller. Such a system matches anesthetic agent requirements to the needs of each individuum and thus allows an unbiased evaluation of the influence of nitrous oxide. Two groups of patients are compared: one ventilated with a oxygen-air mixture and one with oxygen-nitrous oxide mixture. Anesthesia is provided by a "dual-loop" which adapts propofol and remifentanil target concentrations to maintain a bispectral index between 40 and 60 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
- 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
- •General anaesthesia with controlled ventilation
排除标准
- •Age lower than 18 years
- •Pregnant woman
- •Allergy to the propofol or to a muscle myorelaxant
- •Patients receiving a psychotropic treatment
- •Presence of a central neurological disorder or a lesion cerebral
- •Patients having an anomaly of blood cells count preoperative biological assessment
- •Patients having had an anaesthesia in the previous month
研究组 & 干预措施
1
ventilation with air and oxygen
干预措施: air (Drug)
2
ventilation with nitrous oxide and oxygen
干预措施: Nitrous oxide (Drug)
结局指标
主要结局
Measure: influence of nitrous oxide on the automated administration of propofol and remifentanil.
时间窗: during anesthesia
次要结局
- Measure: consequences of the use of nitrous oxide on the performance of the automated administration system.(during anesthesia)
- Influence of Gender(during anesthesia)