Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used
研究概览
简要总结
The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.
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 (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 55 years, status ASA II
- •Carotid endarterectomy elected surgery
- •Signed informed consent
排除标准
- •Related to the patients:
- •Histories of hypersensibility in both products used in the study
- •uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
- •Severe cardiac failure (FEVG < 30 %)
- •Major lung or airways disease and\or required per-operating FiO2> 35 %
- •Elevated intracranial pressure
- •Pregnancy, breast feeding
- •Major protected, under supervision, under guardianship
- •Every patient entering within the framework of the contraindications indicated to §4.3 of the summary of the characteristics of tested products (LENOXe ™ (xenon 100 % v/v), sevoflurane)
- •Related to the surgery:
- •Controlateral carotid stenosis superior to 70 % and\or preoperative indication in the implementation per-operating of a carotid shunt
- •Surgery realized within the framework of an emergency
- •Combined Surgery
研究组 & 干预措施
sévoflurane
hypnotic use in standard general anesthesia
干预措施: sévoflurane (Drug)
LENOXe™ (xénon 100 % v/v)
Safety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person
干预措施: xenon (Drug)
结局指标
主要结局
Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used
时间窗: Pre-op, every min from 1-90 min during maintenance phase
次要结局
- cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient(During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward)