E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Xenon anesthesia in cardiac surgery |
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E.1.1.1 | Medical condition in easily understood language |
Xenon anesthesia in cardiac surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
The aim of this study is to assess whether opioid-based xenon-anaesthesia,as compared to opioid-based sevoflurane anaesthesia, can be safely administered to patients undergoing off-pump coronary artery bypass surgery. |
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E.2.2 | Secondary objectives of the trial |
Evaluation of:
- MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions; postoperative coronary.
- Any cerebrovascular accident not included in MACCE
- Any complication occurring in the early postoperative period and not mentioned above (i.e. wound infection, bleeding)
- Duration of postoperative intensive care unit and hospital stay
- Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)
- Occurrence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM or CAM-ICU for patients in ICU), to be assessed in combination with the Mini-Mental State Examination (MMSE)
- Incidence of further AE, SAE and SUSAR not included above
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with coronary artery disease scheduled for elective OPCAB-surgery
- Patients willing and able to complete the requirements of this study
- Ejection Fraction > 30%
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E.4 | Principal exclusion criteria |
- Lack of informed consent
- Age < 18 years
- Pregnancy
- COPD GOLD > II
- Renal dysfunction defined as serum-creatinine > 1.5 mg/dl
- Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
- Single vessel grafting
- Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression), history of stroke with residuals, increased intracranial pressure
- Hypersensitivity to the study medication
- Presumed uncooperativeness or legal incapacity
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E.5 End points |
E.5.1 | Primary end point(s) |
The feasibility and safety of xenon application compared to sevoflurane application after coronary artery bypass graft surgery, as assessed by Depth of anaesthesia, Arterial and peripheral oxygen saturation, Perianaesthetic haemodynamic profile, Renal function and Requirement for blood (product) transfusion.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after discharge from the hospital. |
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E.5.2 | Secondary end point(s) |
- MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions; postoperative coronary.
- Any cerebrovascular accident not included in MACCE
- Any complication occurring in the early postoperative period and not mentioned above (i.e. wound infection, bleeding)
- Duration of postoperative intensive care unit and hospital stay
- Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)
- Occurrence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM or CAM-ICU for patients in ICU), to be assessed in combination with the Mini-Mental State Examination (MMSE)
- Incidence of further AE, SAE and SUSAR not included above
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after discharge from the hospital. |
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | No |
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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Last visit, last subject i.e. 6 months after last patient's discharge. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |