Actively 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.
Led by Moscow Clinical Scientific Center · Updated on 2023-04-26
130
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
M
Moscow Clinical Scientific Center
Lead Sponsor
N
Negovsky Reanimatology Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 45 to 74 years
- Primary operable breast cancer without prior chemotherapy
- Cytologically confirmed malignant breast tumor of stages IA-IIA (T1-2, N0, M0)
- Signed informed consent
You will not qualify if you...
- Acute stroke within the past 6 months
- Heart attack within the past 6 months
- Acute arterial thrombosis within the past 6 months
- Acute venous thromboembolism within the past 6 months
- Subarachnoid hemorrhage within the past 3 months
- Chronic kidney disease stage 3B to 5
- Severe chronic heart failure (NYHA class 3-4)
- Pregnancy
- History of cancer at another location
- History of drug addiction
- History of autoimmune diseases
- Withdrawal of consent after randomization
- Incomplete surgical intervention with unresected lesions within 2 weeks post-operation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Moscow Scientific Clinical Center
Moscow, Russia, 111123
Actively Recruiting
Research Team
V
Valerii Subbotin, PhD
CONTACT
K
Kristina Kadantseva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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