Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xenon and propofol | Active Comparator |
| |
| propofol | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon and propofol | Drug | xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative haemodynamic stability | Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption | intra-operative |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28598913 | Derived | Al Tmimi L, Devroe S, Dewinter G, Van de Velde M, Poortmans G, Meyns B, Meuris B, Coburn M, Rex S. Xenon as an Adjuvant to Propofol Anesthesia in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery: A Pragmatic Randomized Controlled Clinical Trial. Anesth Analg. 2017 Oct;125(4):1118-1128. doi: 10.1213/ANE.0000000000002179. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014978 | Xenon |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010636 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| propofol | Drug | propofol target controlled infusion (target 1.5-2.5µg/ml) |
|
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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |