Status:
RECRUITING
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.
Lead Sponsor:
Moscow Clinical Scientific Center
Collaborating Sponsors:
Negovsky Reanimatology Research Institute
Conditions:
Anesthesia
Breast Cancer
Eligibility:
FEMALE
45-74 years
Phase:
NA
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04800393
Start Date
March 29 2022
End Date
April 1 2028
Last Update
April 26 2023
Active Locations (1)
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1
Moscow Scientific Clinical Center
Moscow, Russia, 111123