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临床试验/NCT02671084
NCT02671084终止4 期

Effect of Sevoflurane on CKMB Release After PCI With Drug-eluting Stents: a Randomised Trial

Instituto Dante Pazzanese de Cardiologia1 个研究点 分布在 1 个国家目标入组 701 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
701
试验地点
1
主要终点
Measure level of Ck-MB in all patients

研究概览

简要总结

Increase in CK-MB after percutaneous coronary angioplasty more than 100% of baseline can represents a problem to the patients resulting in increase of morbidity and mortality.

Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty.

Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.

详细描述

Several published clinical studies have shown the benefit of using inhaled anesthetic agents in patients undergoing coronary artery bypass graft(CABG). These benefits involve functional state of the heart and reduction damage to the organ. These events are related to intracellular phenomena that result in intracellular calcium homeostasis giving physical and functional benefits to the heart. Also disclosed is a modulation of the inflammatory response to endothelial level with resulting protective character to the coronary bed.

Patients submitted of coronary angioplasty procedures can release in varying degrees of creatine kinase, MB isoform (CK - MB), on the order of 30% of all angioplasty. Even in smaller increases than 3 times baseline, a criterion that defines myocardial infarction, clinical impact can already be found. Increase in CK-MB more than 100% of baseline can represents a problem to the patients. This elevation of CK - MB is associated with various factors such as age, characteristic of the lesion, clinical status of the patient, inferring that endovascular procedures of coronary, simple or complex, have associated myocardial damage, which depending on the intensity of the damage, results in increased morbidity and mortality.

BACKGROUND AND OBJECTIVES:

Check for reduction in the percentage of patients that release CK -MB at levels above the 100% baseline in patients anesthetized with sevoflurane compared to the control group. Possibly patients who will receive sevoflurane experience a higher level of cardiac cell protection with lower incidence in the release of CK - MB values in excess of 100% baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender.
  • Patients with coronary artery disease candidates for coronary angioplasty stent.
  • Cardiac catheterization on an urgent basis.
  • Coronary angioplasty in elective and urgency.
  • Age less than 80 years.

排除标准

  • Patients aged greater than or equal of 80 years.
  • Angioplasty balloon catheter statement.
  • Myocardial infarction with ST-segment elevation.
  • Angioplasty in saphenous vein grafts in patients after surgical revascularization.
  • Patient pregnant.
  • Dialytic insufficiency renal.
  • Patients submited a urgent cardiac catheterization but not progress with coronary angioplasty stent.

研究组 & 干预措施

Sevoflurane Group

Experimental

Sevoflurane Group called group A patients will receive sevoflurane. The patients of group A will receive facial mask properly attached to your face, inspiratory fraction of sevoflurane 3%, with therapeutic target of 1.2% expired fraction into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. This procedure is sufficient to induce the pre anesthetic conditioning in the group exposed to sevoflurane. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure.

干预措施: sevoflurane (Drug)

Control Group

Placebo Comparator

Control Group called group B patients who will not receive sevoflurane. The patient of group B will receive facial mask properly attached to your face into spontaneously breathing.This exposure will during 30 min. Than, the mask will remove of the face and the patient will spontaneously breathing in ambient air during 10 min. After the end of this exhibition, patients will be allowed to enter the catheterization laboratory for angioplasty, no more any anesthetic agent will be administer until the end of his procedure.

干预措施: sevoflurane (Drug)

结局指标

主要结局

Measure level of Ck-MB in all patients

时间窗: 24 hours after coronary intervention

次要结局

  • Length of stay in hospital(30 days after coronary intervention)
  • Length of stay in Intensive Care Unit (UCI)(30 days after coronary intervention)
  • mortality rate(1 year after coronary intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RONALDO ROSSI JUNIOR

Principal Investigator

Instituto Dante Pazzanese de Cardiologia

研究点 (1)

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