Does Anesthesia Technique Affect the Presence of Circulating Tumor Cells in Primary Breast Carcinoma? A Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 221
- 试验地点
- 2
- 主要终点
- Number of CTC before and after administration of anesthetics
研究概览
简要总结
Serious concern about the role of anesthesia in tumor recurrence has considerably risen over years, but the lack of surrogate markers for tumor spreading made trials addressing this issue difficult to realize. In breast cancer patients CTC positivity has been recently recognized as an independent prognostic factor. In this respect, we postulated that in a first step changes in the number of CTC after general anesthesia would help to determine the effect of anesthesia on this tumor marker.
详细描述
Patients with primary breast cancer will be randomized to either propofol or sevoflurane anesthesia for curative surgery. CTC will be determined in the pre- as well as postoperative phase and the kinetic of CTC in the two groups will be compared.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sevoflurane
General anesthesia using Sevoflurane
干预措施: Sevoflurane (Drug)
Propofol
General anesthesia using propofol TCI
干预措施: Propofol (Drug)
结局指标
主要结局
Number of CTC before and after administration of anesthetics
时间窗: 5 days
次要结局
未报告次要终点