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Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer. Monocentric Study Feasibility.


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer. Monocentric Study Feasibility.


The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical
and echocardiographic monitoring. In the case of treatment for breast cancer, surgery
requiring general anesthesia may follow chemotherapy. Although a possible interaction
between general anesthetics and anthracyclines on systolic function is only rarely
mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were
observed in patients treated or previously treated with anthracyclines. The determination of
concentration of BNP is a diagnostic tool used in the detection of heart failure and acute
coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial
function, and an increase in interest rates may precede any other biological changes. In a
patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP
concentration may persist for some months after exposure, and that, whatever the doses
received. The question of a possible synergism between cardiotoxic anthracyclines and
anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the
BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge,
there is very little data regarding a possible synergism between cardiotoxic anthracyclines
and anesthetic agents.


Inclusion Criteria:



- Women over 18 years with effective contraceptive method (if applicable)

- NT-proBNP <125 pg / ml

- ASA 1 or 2,

- Breast cancer histologically proven

- Mastectomy or lumpectomy

- Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy
with anthracyclines,

- Patients who received the briefing and signed the informed consent

- Patients affiliated to a social security system.

Exclusion Criteria:

- Patients for whom the maintenance of general anesthesia does not use halogenated.

- Renal impairment: Creatinine clearance <60 ml / min,

- Patients who for reasons psychological, social, family or geographical could not be
treated or monitored regularly according to the criteria of the study, patients
deprived of liberty or under guardianship.

- Presence of a cardiopathy

- Pregnant Women

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not

Outcome Description:

Describe the evolution of the concentrations of NT-proBNP, through repeated dosing during general anesthesia in patients operated on for breast cancer and anthracycline-sensitized or not

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

GEKIERE Jean Pierre, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: National Security Agency of Medicines and Health Products

Study ID:

IB2009-39

NCT ID:

NCT01754597

Start Date:

September 2009

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Patients with breast cancer requiring surgical management with general anesthesia
  • Breast Neoplasms

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