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Clinical Trials/NCT01754597
NCT01754597
Completed
Not Applicable

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.

Institut Bergonié1 site in 1 country54 target enrollmentStarted: September 1, 2009Last updated:
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
1
Primary Endpoint
Pre-operative Concentration of NT-proBNP

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Pre-operative Concentration of NT-proBNP

Time Frame: Before breast surgery

Mean concentration of NT-proBNP measured before surgery.

Concentration of NT-proBNP at the End of Intervention

Time Frame: At the end of breast surgery

Mean concentration of NT-proBNP measured at the end of intervention

Post-operative Concentration of NT-proBNP

Time Frame: 24 hours after breast surgery

Mean concentration of NT-proBNP measured 24 hours after breast surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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