Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines

NCT ID: NCT01754597

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Participants not previously treated with anthracyclines

No anthracycline treatment in the 6 months prior to inclusion.

Group Type: OTHER

Dosage of B-type natriuretic peptide (NT-proBNP)

Intervention Type: OTHER

NT-proBNP concentration assessed at the following time points :

• T0: before induction of general anesthesia, NT-proBNP measurement
• T1: 30 minutes after induction of general anesthesia
• T2: at the end of the procedure
• T3: in the postoperative period, 6 hours after the end of the procedure
• T4: in the postoperative period, 24 hours after the end of the procedure

Participants previously treated with anthracyclines

Group Type: OTHER

Dosage of B-type natriuretic peptide (NT-proBNP)

Intervention Type: OTHER

NT-proBNP concentration assessed at the following time points :

• T0: before induction of general anesthesia, NT-proBNP measurement
• T1: 30 minutes after induction of general anesthesia
• T2: at the end of the procedure
• T3: in the postoperative period, 6 hours after the end of the procedure
• T4: in the postoperative period, 24 hours after the end of the procedure

Interventions

Dosage of B-type natriuretic peptide (NT-proBNP)

NT-proBNP concentration assessed at the following time points :

• T0: before induction of general anesthesia, NT-proBNP measurement
• T1: 30 minutes after induction of general anesthesia
• T2: at the end of the procedure
• T3: in the postoperative period, 6 hours after the end of the procedure
• T4: in the postoperative period, 24 hours after the end of the procedure

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GEKIERE Jean Pierre, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Institut Bergonié

Bordeaux, Aquitaine, France

Countries

France

Other Identifiers

IB2009-39

Identifier Type: -

Identifier Source: org_study_id