E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate, during the maintenance period of general anaesthesia at comparable depths, the quantity of propofol (mg) administered (adjusted to the patient body surface area and the anaesthesia maintenance duration) with Xenon in inspiratory concentrations of 50% (45%-55%) and 70% (65%-75%), delivered by a Felix Dual® ventilator, versus total i.v. anaesthesia in ASA III patients presenting stable coronary heart disease and undergoing laparotomy |
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E.2.2 | Secondary objectives of the trial |
To assess recovery parameters To collect safety data, including haemodynamic, respiratory and laboratory parameters
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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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E.5 End points |
E.5.1 | Primary end point(s) |
Quantity of propofol (mg) administered during the anaesthesia maintenance adjusted to the patient body surface area and the anaesthesia maintenance duration |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |