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.

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).

Inclusion criteria

• 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.

Exclusion criteria

• 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).