Anesthesia, Coronary Artery Disease
Conditions
Keywords
xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery
Brief summary
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
Detailed description
The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events. This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.
Interventions
DRUGXenon
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
DRUGsevoflurane
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 * Pregnancy * chronic obstructive pulmonary disease (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, significant stenosis of carotid arteries, increased intracranial pressure * Hypersensitivity to the study medication * Presumed uncooperativeness or legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility/Safety of xenon anesthesia | Intraoperatively | assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebral events (MACCE) | up to six months after surgery | death from any cause; perioperative myocardial infarction and stroke |
| Incidence and duration of postoperative delirium | up to five days after surgery | assessed with the Confusion Assessment Method (CAM-ICU) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other secondary efficacy/safety measures | up to five days after surgery | Perioperative blood loss |
| other secondary efficacy/safety measures | up to five days after surgery | Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II) |
Countries
Belgium
Outcome results
None listed