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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.

NCT04800393 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-04-26

No results posted yet for this study

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

Conditions

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

Sponsors & Collaborators

  • Negovsky Reanimatology Research Institute

    collaborator OTHER_GOV

  • Moscow Clinical Scientific Center

    lead OTHER

Principal Investigators

  • Valerii Subbotin, PhD · Moscow Scientific Clinical Center

  • Valery Likhvantsev, PhD · Negovsky Reanimatology Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2023-07-01
Completion
2028-04-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800393 on ClinicalTrials.gov