Quality of Awakening and Impact on Cognitive Function After Administration of Sugammadex in Robotic Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- average score obtained on awakening according to specific test
研究概览
简要总结
With the aim of enhancing the quality of surgery, the robotic cystectomy is often conducted using continuous intravenous infusion of curare, which ensures maximum neuromuscular relaxation until the end of the intervention. Sugammadex, administered for the reversal of deep neuromuscular blocked, enable rapid awakening. Moreover, Sugammadex seems to have a positive effect also on the recovery of cognitive function, psychomotor coordination and mental ability, effects undocumented in Literature.
The aim of the investigators study was to assess whether the reversal with sugammadex after intraoperative continuous infusion of rocuronium, can improve the quality of awakening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •ASA score ≤ III
- •Patients underwent robotic cystectomy
排除标准
- •Cerebrovascular disease
研究组 & 干预措施
neostigmine
this arm will receive neostigmine at the end of the surgery
干预措施: Neostigmine (Drug)
sugammadex
this arm will receive sugammadex at the end of the surgery
干预措施: sugammadex (Drug)
结局指标
主要结局
average score obtained on awakening according to specific test
时间窗: 16 months
cognitive function as assessed by the Mini Mental State Exam; quality of awakening as assessed by the Observer's Assessment of Alterness/sedation
次要结局
未报告次要终点
研究者
Ester Forastiere
Dr
Regina Elena Cancer Institute