BridgeMD
Compares treatment options for Anesthesia
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.
ClinicalTrials.gov ID: NCT04800393
What this study is testing
What is Sevoflurane?
Sevoflurane is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 74, women only
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.