The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery: a Prospective Double-Blind Randomized Clinical Trial (TeMP - Trial).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Neutrophil-lymphocyte ratio
研究概览
简要总结
Even decade ago it was believed that the choice method of anesthesia did not affect the course of the oncological process, but recent evidence has begun to emerge that inhalation anesthesia vs TIVA is associated with a higher number of adverse outcomes. Apparently, it makes sense to conduct mRCT in order to assess the effect of IA on immune system in patients operated on for breast cancer comprehensively. The results of that kind of RCT may finally give us an answer whether the choice of anesthesia affects the immune status of patients undergoing surgery for breast cancer. The evaluation of complications and long-term survival will allow to recommend to use or not to use IA for this type of surgery.
Objective: The Impact of Inhalation vs Total Intravenous Anesthesia on the Immune Status and Mortality in Patients Undergoing Breast Cancer Surgery
详细描述
The power calculation for this study was based on an assessment of Neutrophil-lymphocyte ratio (NLR) in patients undergoing breast cancer resection with total intravenous and inhalation anesthesia in two studies:
- Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46)
- Ní Eochagáin A. et al., 2018 - 116 patients (PMID: 29457215, TIVA group: NLR = 3.20 ± 1.37; inhalation group: NLR = 4.10 ± 1.90).
The pooled mean NLR in the TIVA group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78.
Difference in means (effect size): 0.78, for level α=0.05, power 1-β=80% and expected standard deviation of 1.5, 65 patients in each group should be recruited, taking into account a 10% margin (total number of patients: 130).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The age of the patients is from 45 to 74 years;
- •Primary operable breast cancer (BC) without prior chemotherapy;
- •Cytologically confirmed breast malignant tumor of IA-IIA stages (T1-2, N0, M0);
- •Signed informed consent.
排除标准
- •Acute cerebrovascular accident (CVA) occurred in the previous 6 months;
- •Myocardial infarction (MI) occurred in the previous 6 months;
- •Acute arterial thrombosis occurred in the previous 6 months;
- •Acute venous thromboembolism occurred in the previous 6 months;
- •Subarachnoid hemorrhage occurred during the previous 3 months;
- •Chronic kidney disease (CKD) stage 3B-5;
- •Сhronic heart failure (NYHA) class 3-4;
- •Pregnancy;
- •History of another location cancer;
- •History of drug addiction;
- •Autoimmune diseases in history;
- •Post-randomization: withdrawal of informed consent (refusal to continue participating in the study);
- •Post-randomization: surgical intervention, performed not in full (verified non-resected lesions in the early p/o period, 2 weeks p/o).
研究组 & 干预措施
Inhalation anesthesia
干预措施: Sevoflurane (Drug)
Total intravenous anesthesia
干预措施: Propofol (Drug)
结局指标
主要结局
Neutrophil-lymphocyte ratio
时间窗: 24 hours after surgery
Absolute number of neutrophils divided by the absolute number of lymphocytes
次要结局
- Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +)(24 hour after surgery)
- IL-6(24 hour after surgery)
- Matrix metallopeptidase 9(24 hour after surgery)
- C-reactive protein(24 hour after surgery)
- Natural killer cells of blood (CD3-CD16 +)(24 hour after surgery)
研究者
Valerii Subbotin
PhD
Moscow Clinical Scientific Center