Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

Detailed Description
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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.

Official Title
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The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study

Conditions
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Coronary Artery Disease, Anesthesia

Intervention / Treatment
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* Drug: Xenon
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Xenon<br>gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery | Drug: Xenon<br>* general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)<br>|
| Active Comparator: Drug: Sevoflurane<br>inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery | Drug: sevoflurane<br>* general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility/Safety of xenon anesthesia | assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebral events (MACCE) | death from any cause; perioperative myocardial infarction and stroke | up to six months after surgery | 
| Incidence and duration of postoperative delirium | assessed with the Confusion Assessment Method (CAM-ICU) | up to five days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery