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 STABLE CORONARY HEART DISEASE - General anaesthesia with xenon

AIR LIQUIDE0 个研究点目标入组 240 人开始时间: 2008年3月17日最近更新: 2022年8月8日

研究概览

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•Patient from 50 to 75 years old (both included)
•ASA (American Society of Anaesthesiologists) physical status III
•Patient with coronary heart disease, stable during the last 6 months prior to selection
•Surgical operation: laparotomy
•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

•Patient with severe impairment of cardiac function (Left Ventricular Ejection Fraction < 35% evaluated within 12 months prior to selection)
•Patient with drug-eluding stent
•Woman of child-bearing potential not implementing adequate contraceptive methods
•Pregnant or lactating woman
•Surgical procedure in emergency
•Chronic therapy with opioids for pain relief
•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 allergic disease/hypersensitivity or allergy/hypersensitivity to any drugs used during the study, to silicone or to latex
•-Severely impaired hearing
•-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 months prior to selection
•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 selection

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