RecruitingNot ApplicableNCT04800393

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 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).


Sponsor

Moscow Clinical Scientific Center

Enrollment

130 participants

Start Date

Mar 29, 2022

Study Type

INTERVENTIONAL

Conditions

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 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


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of anesthesia used during breast cancer surgery — inhaled gas anesthesia versus total intravenous anesthesia — to see which type better preserves the immune system and whether that affects long-term survival outcomes. **You may be eligible if...** - You are between 45 and 74 years old - You have early-stage primary breast cancer (Stage IA-IIA) that has not been previously treated with chemotherapy - Your breast cancer diagnosis has been confirmed by tissue testing - You are scheduled for breast cancer surgery **You may NOT be eligible if...** - You have had a recent stroke - You have severe heart, lung, or other serious medical conditions - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSevoflurane

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

DRUGPropofol

propofol-based total intravenous anesthesia during breast cancer surgery


Locations(1)

Moscow Scientific Clinical Center

Moscow, Russia

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NCT04800393


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