Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.

Study Overview
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Brief Summary
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The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.

Official Title
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Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial

Conditions
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Coronary Artery Disease, Anesthesia

Intervention / Treatment
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* Drug: Xenon and propofol
* Drug: propofol


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 COPD GOLD >II Renal dysfunction defined as serum-creatinine >1.5mg/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, low preoperative cognitive state (MMSE at baseline <25), history of stroke with residuals, 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 |
| --- | --- |
| Active Comparator: Xenon and propofol<br> | Drug: Xenon and propofol<br>* xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)<br>|
| Placebo Comparator: propofol<br> | Drug: propofol<br>* propofol target controlled infusion (target 1.5-2.5µg/ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative haemodynamic stability | Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption | intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE (major adverse cardiac and cerebral events) | Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke | up to six months postoperative | 
| cerebrovascular accident not included in MACCE | cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit) | up to six months postoperative | 
| postoperative renal function | postoperative renal function as assessed by serum creatinine and BUN levels) | up to five days postoperative | 
| requirement for blood(product) transfusion | requirement for blood(product) transfusion | up to five days postoperative | 
| length of stay | requirement for blood(product) transfusion | participants will be followed for the duration of hospital stay, an expected average of 10 days. | 
| severity of postoperative critical illness | Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score | up to five days postoperative | 
| incidence and duration of postoperative delirium | incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination | participants will be followed for the duration of hospital stay, an expectged average of 10 days | 
| incidence of further AE, SAE and SUSAR |  | participants will be followed for the duration of hospital stay, an expected average of 10 days | 

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