Total IntraVenous AnesthesIa and ReCurrence-free Survival AfTer EsOphageal CanceR SurgerY
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,614
- 试验地点
- 1
- 主要终点
- Recurrence-free survival
研究概览
简要总结
The investigators propose to compare recurrence-free survival in patients having potentially curative (Stages 1-3) surgery for esophageal cancer who will be randomly assigned to propofol-based total intravenous anesthesia or sevoflurane-based balanced general anesthesia.
详细描述
The investigators will test the primary hypothesis that recurrence-free survival after esophageal cancer surgery is longer in patients randomized to propofol-based total intravenous anesthesia than to volatile sevoflurane anesthesia.
The investigators will test the secondary hypotheses that propofol-based total intravenous anesthesia: 1) speeds discharge from the ICU; 2) speeds discharge from the hospital; and, 3) improves the quality of recovery, as assessed by QoR-15 on postoperative day 2.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary esophageal cancer without known extension beyond the esophagus. (i.e. believed to be Tumor Stage 1-3).
- •Scheduled for potentially curative esophageal cancer surgery.
- •Written informed consent, including willingness to be randomized to intravenous versus volatile anesthesia.
排除标准
- •Previous surgery for esophageal cancer (except diagnostic biopsies) Age <18 or >85 years old.
- •ASA Physical Status ≥
- •Any contraindication to propofol or sevoflurane.
- •Other cancer not believed by the attending surgeon to be in long-term remission.
- •Systemic disease believed by the attending surgeon to present ≥25% two- year mortality.
研究组 & 干预措施
Propofol-based total intravenous anesthesia
Propofol-based total intravenous anesthesia. A target-controlled infusion will be set to 2-4 µg/ml plasma concentrations, and varied as clinical necessary.
干预措施: Propofol-based total intravenous anesthesia (Drug)
Sevoflurane intravenous anesthesia
Anesthesia will be maintained with sevoflurane, typically at an end-tidal concentration of 0.6-1.0 MAC, but adjusted as clinically necessary
干预措施: Sevoflurane intravenous anesthesia (Drug)
结局指标
主要结局
Recurrence-free survival
时间窗: 4 years
Patients who did not experience cancer recurrence and/or death.
次要结局
- QoR-15(2 days)
- Hospital duration(Up to 100 months)
- ICU duration(From ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 100 months)