A Pilot Study to Evaluate the Impact of Dexmedetomidine on Postoperative Tumor Recurrence in Patients With Primary Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- study feasibility
研究概览
简要总结
Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. The purpose of present study is to examine whether utilization of dexmedetomidine in patients undergoing surgery for primary breast cancer increases breast cancer recurrence and metastasis, and to investigate its effects on the patients' immune system.
详细描述
Women diagnosed with breast cancer undergoing elective surgery under general anesthesia will be randomly allocated to dexmedetomidine group or control group. Patients from both groups will receive midazolam, propofol, fentanyl, remifentanil and CIS atracurium for total intravenous anesthesia. BIS value will be controlled between 40-60 during surgery. Patients of dexmedetomidine group will receive a loading does of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery. Patients of control group will receive same amount of normal saline. Patients will be followed up for 36 months to measure the incidence of cancer recurrence and metastasis. Serum form patients of both groups will be collected at 24 h after surgery. The number of CD3+ , CD4+, CD8+ cells and NK cells in the serum will be compared between the two groups. Serum levels of IFN-γ, IL-12，IL-4 and VEGF will also be measured and 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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA grade I-III
- •Age range of 18 to75
- •Patients diagnosed primary breast cancer
- •Patients will have elective mastectomy
排除标准
- •with history of breast operation
- •Patients diagnosed with inflammatory breast
- •Severe mental or physical illnesses(like liver, renal, brain or lung disease)
- •with history of opioid addiction
- •Patients diagnosed metastatic breast cancer
- •Contradictions or an allergy to Dexmedetomidine
研究组 & 干预措施
Dexmedetomidine
Patients of dexmedetomidine group will receive a loading dose of 1ug/kg dexmedetomidine since 15 mins before induction, and receive another 1ug/kg of dexmedetomidine at a rate of 0.5ug/kg/h for 2 continuous hours during surgery.
干预措施: Dexmedetomidine (Drug)
saline
Same amount of saline will be administrated.
干预措施: Saline (Drug)
结局指标
主要结局
study feasibility
时间窗: from May 2015 to August 2019
recruitment and dropout rates
次要结局
- the number/percentage of blood CD8+ cells(at 24 hours after surgery)
- recurrence-free survival(up to 5 years after surgery)
- the number/percentage of blood NK cells(at 24 hours after surgery)
- the number/percentage of blood CD19+ cells(at 24 hours after surgery)
- the number of blood CD3+ cells(at 24 hours after surgery)
- the number/percentage of blood CD4+ cells(at 24 hours after surgery)
- overall survival(up to 5 years after surgery)
- the ratio of CD4+ cells / CD8+ cells(at 24 hours after surgery)