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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sevoflurane, Propofol.
- Who it may be relevant to
- Registry conditions: Anesthesia, Breast Cancer. Basic parameters: 45 years — 74 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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).
Overview
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
Detailed description
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:
1. Cho J.S. et al., 2017 - 48 patients (PMID: 28924368, TIVA group: NLR = 3.37 ± 1.27; inhalation group: NLR = 3.85 ± 1.46) 2. 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).
Interventions
- Drug Sevoflurane
induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery - Drug Propofol
propofol-based total intravenous anesthesia during breast cancer surgery
Primary outcome measures
- Neutrophil-lymphocyte ratio [Time frame: 1 hour after surgery]
- Neutrophil-lymphocyte ratio [Time frame: 24 hours after surgery]
Secondary outcome measures (10)
- Matrix metallopeptidase 9 [Time frame: 1 hour after surgery]
- Matrix metallopeptidase 9 [Time frame: 24 hour after surgery]
- C-reactive protein [Time frame: 1 hour after surgery]
- C-reactive protein [Time frame: 24 hour after surgery]
- Natural killer cells of blood (CD3-CD16 +) [Time frame: 1 hour after surgery]
- Natural killer cells of blood (CD3-CD16 +) [Time frame: 24 hour after surgery]
- Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +) [Time frame: 1 hour after surgery]
- Immunoregulatory index of T helpers (CD3 + CD4 +) / cytotoxic T cells (CD3 + CD8 +) [Time frame: 24 hour after surgery]
- IL-6 [Time frame: 1 hour after surgery]
- IL-6 [Time frame: 24 hour after surgery]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Russia · 1 center
- Moscow Scientific Clinical Center — Moscow
Identifiers
NCT: NCT04800393 · TeMP 2021