The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
研究概览
简要总结
The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.
详细描述
The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.
Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery disease scheduled for elective CABG
- •Patients willing and able to complete the requirements of this study
- •Ejection Fraction > 50%
- •EuroSCORE ≤ 8
- •men and women >= 50 yrs
- •women without childbearing potential
- •ASA Score II-IV
排除标准
- •Lack of informed consent
- •EuroSCORE < 8
- •MMSE < 24
- •Age < 50 years
- •COPD GOLD > II, increased need of oxygen
- •Renal dysfunction
- •Liver function disorders
- •Acute coronary syndrome during the last 24 hours; hemodynamic instability
- •Requirement of inotropic support
- •Off-pump-surgery
- •Disabling neuropsychiatric disorders
- •History of stroke with residuals
- •Hypersensitivity to the study anaesthetics
- •Increased intracranial pressure
- •Pregnancy and lactation period
- •Women of childbearing potential
- •Presumed uncooperativeness or legal incapacity
- •Participation in a concomitant trial
研究组 & 干预措施
Xenon
Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
干预措施: Xenon (Drug)
Sevoflurane
Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
时间窗: an average of 4 to 6 hours
The feasibility of xenon application compared to sevoflurane application will be assessed by: * The depth of anaesthesia level * The peri-anaesthetic respiratory profile * The peri-anaesthetic haemodynamic profile The following safety parameters will be assessed: * Doses and concentration of study treatments * Trans-esophageal echocardiography * Measures of renal function * Intra-operative blood loss and amount of transfused blood/products * Need for hemodynamic and inotropic support * The patient's regional cerebral tissue oxygenation rSO2 * The incidence of AE and SAE
次要结局
- Secondary efficacy and safety criteria(6 days)
- all cause mortality and contentment questioning(1 year)