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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2028-04-01

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Anesthesia Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Inhalation anesthesia

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery

Total intravenous anesthesia

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

propofol-based total intravenous anesthesia during breast cancer surgery

Interventions

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Sevoflurane

induction of anesthesia with propofol, maintenance of anesthesia with sevoflurane during breast cancer surgery

Intervention Type DRUG

Propofol

propofol-based total intravenous anesthesia during breast cancer surgery

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No