Coronary Artery Disease Clinical Trial
Official title:
The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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