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临床试验/NCT02019797
NCT02019797Unknown4 期

Desflurane-induced Myocardial Protection in Aortic Valve Surgery: A Pilot Study

Nobuyuki Katori1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
50
试验地点
1
主要终点
Troponin I

研究概览

简要总结

This study examines pharmacological preconditioning and post conditioning of desflurane by comparing cardiac troponin release in patients receiving either desflurane or propofol for the aortic valve surgery.

详细描述

Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass are included in the study. Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a TIVA during the surgery. All patients receive a continuous infusion of remifentanil. Biomarker of myocardial damage troponin I is examined at 4 points; T1: after the induction of anesthesia, T2: arrival at ICU, T3: 12 hours after the ICU arrival, T4: 24 hours after the ICU arrival, T5: third post operative day (3POD).

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for aortic valve replacement with use of cardiopulmonary bypass.

排除标准

  • Patients younger than 20 years old.
  • Recent myocardial infarction (within 1 year).
  • Renal dysfunction (GFR less than 50ml/min).
  • Known allergy to study drugs including propofol.

研究组 & 干预措施

Desflurane

Experimental

Desflurane inhalation at 1-2 MAC during surgery.

干预措施: Desflurane (Drug)

Propofol

Active Comparator

5-8 mg/kg/hr infusion during surgery.

干预措施: Desflurane (Drug)

结局指标

主要结局

Troponin I

时间窗: up to 3 days

次要结局

  • Length of ICU stay, Length of hospital stay(up to 2 months after the surgery)
  • Acute myocardial infarction(up to 7 days)

研究者

发起方
Nobuyuki Katori
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nobuyuki Katori

Assistant Professor

Keio University

研究点 (1)

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