Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 13
- 主要终点
- Number of Participants With Myocardial Necrosis (MN)
研究概览
简要总结
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
详细描述
The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op;
Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
- •Cardiac ischaemic risk supported by:
- •History of myocardial infarction older than 1 month and/or
- •Documented Stable angina (asymptomatic ± medical treatment) and/or
- •History of coronary revascularisation, and/or
- •Surgical Risk Index ("Lee" index) ≥
- •Written informed consent
排除标准
- •Unstable angina within the last 30 days,
- •Non controlled arterial Hypertension .
- •Severe Cardiac heart Failure (NYHA IV)
- •Severe Chronic Obstructive Pulmonary Disease
- •Patient already randomized in another ongoing clinical trial
- •Patient with recent myocardial infarction (M.I) (less than one month )
- •Patient already included in a clinical trial
- •History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
- •Malignant hyperthermia
- •Documented Elevated intracranial pressure
- •Preeclampsia or eclampsia
- •Pregnancy and lactation
- •Presumed uncooperativeness or legal incapacity
研究组 & 干预措施
Xenon
0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
干预措施: Xenon (Drug)
sevoflurane
0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Number of Participants With Myocardial Necrosis (MN)
时间窗: 3 Postoperative Days
Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)
次要结局
- Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)(3 Postoperative days)
- Number of Participants With Myocardial Infarction (MI)(3 Postoperative Days)
- Number of Participants With Cerebro-Vascular Event(3 postoperative days)
- Number of Participants With Life-Threatening Arrhythmia(3 Postoperative Days)
- Number of Participants Who Died From Cardiac Origin(3 postoperative days)
- Number of Participants With Composite Endpoint(3 postoperative days)
- Systolic Blood Pressure (SBP)(From pre-induction to recovery of anesthesia)
- Vital Signs (SBP and DBP Changes)(From pre-induction to Postoperative Day 3)
- Vital Signs (Heart Rate Changes)(From pre-induction to Postoperative Day 3)
- Number of Participants With Chest Pain During the 3 Postoperative Days(From Day 0 until Postoperative Day 3)
- Urine Output(From Day 0 until Postoperative Day 1)