Xenon anesthesia in cardiac surgery
Conditions
Interventions
Trade Name: Xenon
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: XENON (133XE)
CAS Number: 14932-42-4
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentratio
Sponsors
University Hospitals of the KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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% 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Lack of informed consent - Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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 ;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. ;Timepoint(s) of evaluation of this end point: 6 months after discharge from the hospital. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: 6 months after discharge from the hospital. | — |
Countries
Belgium
Contacts
Public ContactAnesthesia Research
University Hospitals of the KU Leuven
Outcome results
None listed