Influence of General Anesthesia Versus Spinal Anesthesia on Circulating Tumor Cells in Patients Undergoing Transurethral Resection of Bladder Tumor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- the number of Circulating Tumor Cells
研究概览
简要总结
Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.≤18 Age ≤85，ASAI-III.
- •.Patients with primary bladder cancer of Stage T1 to T4, who are scheduled for transurethral resection of bladder tumor.
- •.Written informed consent.
排除标准
- •History of surgery within 6 months.
- •Contraindications for spinal anesthesia.
- •With a history of any other malignancy.
- •Having received preoperative neoadjuvant therapy.
- •History of long-term opioid use.
- •Combined with autoimmune diseases or having a history of prolonged hormone use or immunosuppressant use within 1 year.
- •Combined with impaired liver function (Child - Pugh C) or renal insufficiency (serum creatinine level over 442μmol•L-1).
- •Known hypersensitivity or suspected allergy to intervention drugs.
- •Proposed postoperative admission to ICU.
结局指标
主要结局
the number of Circulating Tumor Cells
时间窗: on the Day 7~10 after surgery
The number of circulating tumor cells will be measured by collecting 5 ml of venous blood sample.
次要结局
- Nausea Score(at 24 hours after surgery)
- Visual Analogue Scale(at 24 hours after surgery)
- Surgeon Satisfaction(immediately after surgery)
- Patient Satisfaction(within 24 hours after surgery)
- Hospitalization Days(up to 30 days)
研究者
Jie Tian
Principal Investigator
RenJi Hospital