跳至主要内容
临床试验/NCT01757106
NCT01757106已完成2 期

The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
42
试验地点
1
主要终点
Feasibility/Safety of xenon anesthesia

研究概览

简要总结

Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

详细描述

The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events.

This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.

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 (Participant, Investigator)

入排标准

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

入选标准

  • Patients with coronary artery disease scheduled for elective OPCAB- surgery
  • Patients willing and able to complete the requirements of this study
  • Ejection Fraction > 30%

排除标准

  • Lack of informed consent
  • Age < 18 years
  • Pregnancy
  • chronic obstructive pulmonary disease (COPD) GOLD > II
  • Renal dysfunction defined as serum-creatinine > 1.5 mg/dl
  • Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
  • Single vessel grafting
  • Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure
  • Hypersensitivity to the study medication
  • Presumed uncooperativeness or legal incapacity

研究组 & 干预措施

Drug: Xenon

Experimental

gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery

干预措施: Xenon (Drug)

Drug: Sevoflurane

Active Comparator

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery

干预措施: sevoflurane (Drug)

结局指标

主要结局

Feasibility/Safety of xenon anesthesia

时间窗: Intraoperatively

assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation

次要结局

  • Major adverse cardiac and cerebral events (MACCE)(up to six months after surgery)
  • Incidence and duration of postoperative delirium(up to five days after surgery)

研究者

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

prof Dr Steffen Rex

Prof. Dr.

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

Loading locations...

相似试验