Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines (PEPNATB)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Peptide Natriurétique de type B |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
- 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]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
- Depending on the sensitivity to anthracyclines, study the proportion of patients with subclinical heart failure in the general anesthesia during surgery for breast cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 65 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peptide Natriurétique de type B
Peptide Natriurétique de type B
|
Drug: Peptide Natriurétique de type B
Peptide Natriurétique de type B
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | 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
Contacts and Locations| Contact: GEKIERE Jean Pierre, MD | j.gekiere@bordeaux.unicancer.fr | |
| Contact: MATHOULIN PELISSIER Simone, PU-PH | s.mathoulin@bordeaux.unicancer.fr |
| France | |
| Institut Bergonié | Recruiting |
| Bordeaux, Aquitaine, France, 33000 | |
| Contact: GEKIERE Jean Pierre, MD j.gekiere@bordeaux.unicancer.fr | |
| Principal Investigator: GEKIERE Jean Pierre, MD | |
| Study Chair: | GEKIERE Jean Pierre, MD | Institut Bergonié |
More Information
Additional Information:
No publications provided
| Responsible Party: | Institut Bergonié |
| ClinicalTrials.gov Identifier: | NCT01754597 History of Changes |
| Other Study ID Numbers: | IB2009-39 |
| Study First Received: | November 6, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | France: National Security Agency of Medicines and Health Products |
Keywords provided by Institut Bergonié:
|
Patients with breast cancer requiring surgical management with general anesthesia |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Anesthetics Sevoflurane Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on May 23, 2013