NCT01198639已完成不适用
One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 2,044
- 试验地点
- 36
- 主要终点
- Mortality rate during the first year following anesthesia
研究概览
简要总结
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):
- manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
- closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.
Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology patient classification status I, II and III
- •patients aged between 50 and 85 years old
- •born in France
- •surgical procedures lasting more than one hour
排除标准
- •American Society of Anesthesiology patient classification status IV
- •patients born out of France
- •pace-maker
- •surgical procedure on the skull or avoiding an adequate positioning of the bispectral index electrode dementia, history of central nervous system disease (tumor, vascular event, Parkinson disease, ...)
- •psychiatric illness (severe depression or psychosis), patients receiving a psychotropic treatment
- •anesthesia performed during the year before inclusion in this study except for diagnostic procedures
- •allergy to propofol, soja, peanuts, or to sufentanil, remifentanil, or morphine, to a myorelaxant or to an excipient,
- •hypersensibility to sufentanil, to remifentanil, or to other derivate of fentanyl
研究组 & 干预措施
manual administration of iv anesthetics
Active Comparator
干预措施: manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform (Device)
closed-loop administration of iv anesthetics
Experimental
干预措施: closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform (Device)
结局指标
主要结局
Mortality rate during the first year following anesthesia
时间窗: one year after anesthesia
次要结局
- in-hospital and one month mortality(one year after anesthesia)
- intraoperative awareness(one month postoperatively)
- conduct of anesthesia (duration of anesthesia with bispectral index < 45, bispectral index < 40, bispectral index > 60, bispectral index > 65, and burst suppression ratio)(end of anesthesia)
- patients' satisfaction in the postanesthesia care unit (nausea, vomiting, shivering)(end of the stay in the postanesthesia care unit)
- postoperative complication during the hospital stay (ancillary study)(one month after anesthesia)
- major medical events during the first year following anesthesia(one year after anesthesia)
- relation between patients' characteristics and mortality rate during the first year following anesthesia(one year after anesthesia)
- intraoperative parameters, notably hemodynamic parameters, and their relation between them and mortality rate during the first year following anesthesia(one year after anesthesia)
研究者
研究点 (36)
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