Clinical trial NCT01754597: Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Patients with breast cancer requiring surgical management with general anesthesia
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 3 years
Secondary outcomes:
measure: Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: GEKIERE Jean Pierre, MD
role: STUDY_CHAIR
References: