Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
University Hospitals Leuven
Leuven, Belgium
Feasibility/Safety of xenon anesthesia
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
Time frame: Intraoperatively
Major adverse cardiac and cerebral events (MACCE)
death from any cause; perioperative myocardial infarction and stroke
Time frame: up to six months after surgery
Incidence and duration of postoperative delirium
assessed with the Confusion Assessment Method (CAM-ICU)
Time frame: up to five days after surgery
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