Recovery After Sugammadex(TIVA Using Propofol vs Inhalation Anesthesia Using Sevoflurane)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Number of patients with an increase in Bispectral Index after sugammadex injection
研究概览
简要总结
Sugammadex is used to reverse of a neuro-muscular block deep. It has been reported that its administration could induce signs of recovery despite continuation of anesthetic drugs. The goal of the present study is to look is the arte of this event is different according to the primary anesthetic agent used.
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
- None
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
- •adult patients scheduled to receive general anesthesia with muscle relaxation achieved with rocuronium
排除标准
- •Known drug allergy,
- •Contra-indications to the use of propofol, remifentanil, rocuronium, sevoflurane, sugammadex
- •Difficulty to use Bispectral Index monitor
- •Inability to obtain a proper monitoring of muscle relaxation.
研究组 & 干预措施
Propofol-Remifentanil
Anesthesia is maintained with Propofol and Remifentanil; myorelaxation is obtained with rocuronium
干预措施: Sugammadex (Drug)
Sevoflurane-Remifentanil
Anesthesia is maintained with Sevoflurane and Remifentanil; myorelaxation is obtained with rocuronium
干预措施: Sugammadex (Drug)
结局指标
主要结局
Number of patients with an increase in Bispectral Index after sugammadex injection
时间窗: One hour after anesthesia
Increase in Bispectral Index (\> 20) after sugammadex injection
Number of patients with occurence of clinical signs of awakening after sugammadex injection
时间窗: One hour after anesthesia
Clinical signs of awakening after sugammadex are wallowing, eye opening on demand, cough, spontaneous movements, response to simple commands, tearing, ...
次要结局
- T4/T1 ratio after sugammadex injection(One hour after anesthesia)
- Number of patients with side effects due to sugammadex injection(One hour after anesthesia)