EUCTR2007-001979-10-GB进行中（未招募）1 期
AN INTERNATIONAL PHASE III RANDOMISED TRIAL COMPARING THE PROPOFOL CONSUMPTION DURING GENERAL ANAESTHESIA WITH XENON IN INSPIRATORY CONCENTRATIONS OF 50 % AND 70% AND TOTAL IV ANAESTHESIA ALONE IN ASA III PATIENTS WITH INCREASED RISK OF PERIOPERATIVE CARDIAC COMPLICATIONS - General anaesthesia with xenon
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AIR LIQUIDE
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patient = 50 years old
- •ASA (American Society of Anaesthesiologists) Status III
- •Patient with increased risk of perioperative cardiac complications
- •(Revised Cardiac Risk Index)
- •Surgical operation: laparotomy or laparoscopy or orthopaedic surgery
- •Planned duration of general anaesthesia in the range of 2-6 hours
- •Patient willing and able to complete the requirements of this study
- •including the signature of the written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient with severe impairment of cardiac function (Left Ventricular
- •Ejection Fraction < 35%)
- •Patient with drug-eluding stent placed within 12 months prior to
- •Woman of child-bearing potential not implementing adequate
- •contraceptive methods
- •Pregnant or lactating woman
- •Surgical procedure in emergency
- •Chronic opioids pain therapy
- •Serious illness or medical conditions which are possible
- •contra-indication for elective general anaesthesia or administration of
- •intra-operative treatments, or which are interfering with the monitoring
- •devices, such as:
- •- Myocardial infarction within 6 months prior to selection
- •- Any significant history of allergy/hypersensitivity to any drugs used
- •during the study, to silicone or to latex
- •- Severely impaired hearing
- •- Known severe neurological disorders
- •- Any medical condition which does not justify the trial participation
- •in the investigator’s judgement
- •- General anaesthesia within 7 days prior to selection
- •- Laparotomy within 12 3 months prior to selection, only for patients
- •undergoing laparotomy
- •History of drug abuse or psychiatric disorders which would impair the
- •understanding of the necessary information or render medically or
- •legally not able to give written informed consent
- •Concurrent treatment with any other experimental drugs
- •Participation in any other clinical trial within 4 weeks prior to
研究者
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