Sevoflurane-based Volatile Induction and Maintenance of Anaesthesia (VIMA) Strategy Decreases the Risk of Postoperative Delirium in Elderly Patients With Registered Cerebral Hypoxemia Episodes During General Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Regional Cerebral Oxygenation (rSO2)
研究概览
简要总结
The aim of this study is to distinguish possible differences in frequency of delirium after Volatile Induction and Maintenance of Anesthesia and Total Intravenous Anesthesia in case of undeliberate cerebral desaturation during non-cardiac surgery.
详细描述
The aim of the present study is to investigate whether in non-cardiac surgery the frequency of POD after intraoperative undeliberate cerebral saturation could be modulated by the choice of the anesthetic strategy (Volatile Induction and Maintenance of Anesthesia [VIMA] and Total Intravenous Anesthesia [TIVA]). Based on our previous data we hypothesized that incidence of POD would be lower with VIMA compared to TIVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •class III-IV by physical status classification system of American Society of Anesthesiologist (ASA)
- •history of arterial vascular disease (arterial hypertension, myocardial ischemia and/or cerebral vascular disease)
- •undergoing elective non-cardiac surgery (hemicolectomy, hernioplasty, laparoscopic cholecystectomy and laparoscopic hysterectomy)
排除标准
- •stroke or myocardial infarction ≤ 6 months before surgery
- •oncological disease of T2-4N3M1 stage
研究组 & 干预措施
Sevoflurane
Sevoflurane Based Volatile Induction and Maintenance of Anaesthesia
干预措施: Sevoflurane (Drug)
Propofol
Propofol Based Total Intravenous Anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Regional Cerebral Oxygenation (rSO2)
时间窗: Continued the entire surgery
Peripheral tissue oxygen saturation (SpO2)
时间窗: Continued the entire surgery
Non-invasive blood pressure (NIBP)
时间窗: Continued the entire surgery
次要结局
- Plasma concentration of S100b protein(Baseline, 24h and 48h after surgery)
- Number of Incidences of postoperative delirium (POD)(Baseline, 24h and 48h after surgery)