University Hospitals Leuven
Leuven, 3000, Belgium
NCT Number: NCT01757106
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Leuven, 3000, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
Time frame: Intraoperatively
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
Time frame: up to six months after surgery
death from any cause; perioperative myocardial infarction and stroke
Time frame: up to five days after surgery
assessed with the Confusion Assessment Method (CAM-ICU)
Time frame: up to five days after surgery
Perioperative blood loss
Time frame: up to five days after surgery
Requirement for blood (product) transfusion
Time frame: until discharge from the hospital
Duration of postoperative intensive care unit and hospital stay
Time frame: up to five days after surgery
Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score
Time frame: up to five days after surgery
Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance
Time frame: up to five days after surgery
Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)
Universitaire Ziekenhuizen KU Leuven
Other
The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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