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NCT Number: NCT01754597

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Pre-operative Concentration of NT-proBNP

    Time frame: Before breast surgery

    Mean concentration of NT-proBNP measured before surgery.

  2. 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

  3. Post-operative Concentration of NT-proBNP

    Time frame: 24 hours after breast surgery

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

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Official study 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.

Acronym: PEP-NAT-B

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2012
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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