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

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Dosage of B-type natriuretic peptide (NT-proBNP)

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Institut Bergonié

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participants not previously treated with anthracyclines; No anthracycline treatment in the 6 months prior to inclusion.	Other: 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
Other: Participants previously treated with anthracyclines	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative Concentration of NT-proBNP	Mean concentration of NT-proBNP measured before surgery.	Before breast surgery
Concentration of NT-proBNP at the End of Intervention	Mean concentration of NT-proBNP measured at the end of intervention	At the end of breast surgery
Post-operative Concentration of NT-proBNP	Mean concentration of NT-proBNP measured 24 hours after breast surgery	24 hours after breast surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer	Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer; In patients treated with anthracyclines, highlight the factors associated (cumulative dose of anthracycline front, left breast radiotherapy) to subclinical heart failure; In patients treated with anthracyclines, assess describe the relationship between the dose of anthracycline received preoperative and percentage of maximum variation of the concentration of NT-proBNP in the first 24 hours after surgery	3 years

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Study Chair: GEKIERE Jean Pierre, MD, Institut Bergonié

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimated): December 21, 2012

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Anesthesia
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; pro-brain natriuretic peptide (1-76)
• Other Study ID Numbers: IB2009-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO