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临床试验/NCT01754597
NCT01754597已完成不适用

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 Bergonié2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Pre-operative Concentration of NT-proBNP

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

Participants not previously treated with anthracyclines

Other

No anthracycline treatment in the 6 months prior to inclusion.

干预措施: Dosage of B-type natriuretic peptide (NT-proBNP) (Other)

Participants previously treated with anthracyclines

Other

干预措施: Dosage of B-type natriuretic peptide (NT-proBNP) (Other)

结局指标

主要结局

Pre-operative Concentration of NT-proBNP

时间窗: Before breast surgery

Mean concentration of NT-proBNP measured before surgery.

Concentration of NT-proBNP at the End of Intervention

时间窗: At the end of breast surgery

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

Post-operative Concentration of NT-proBNP

时间窗: 24 hours after breast surgery

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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