Anesthesia, Coronary Artery Disease
Conditions
Keywords
xenon anesthesia, Off-pump coronary artery bypass graft surgery
Brief summary
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.
Interventions
DRUGXenon and propofol
xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
DRUGpropofol
propofol target controlled infusion (target 1.5-2.5µg/ml)
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Exclusion criteria
* Lack of informed consent * age \< 18 years * COPD GOLD \>II * Renal dysfunction defined as serum-creatinine \>1.5mg/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, low preoperative cognitive state (MMSE at baseline \<25), history of stroke with residuals, increased intracranial pressure * Hypersensitivity to the study medication * Presumed uncooperativeness or legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative haemodynamic stability | intra-operative | Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence and duration of postoperative delirium | participants will be followed for the duration of hospital stay, an expectged average of 10 days | incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination |
| MACCE (major adverse cardiac and cerebral events) | up to six months postoperative | Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke |
| cerebrovascular accident not included in MACCE | up to six months postoperative | cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit) |
| severity of postoperative critical illness | up to five days postoperative | Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score |
| requirement for blood(product) transfusion | up to five days postoperative | requirement for blood(product) transfusion |
| length of stay | participants will be followed for the duration of hospital stay, an expected average of 10 days. | requirement for blood(product) transfusion |
| incidence of further AE, SAE and SUSAR | participants will be followed for the duration of hospital stay, an expected average of 10 days | — |
| postoperative renal function | up to five days postoperative | postoperative renal function as assessed by serum creatinine and BUN levels) |
Countries
Belgium
Outcome results
None listed