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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002316-12 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Xenon | Experimental | gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery |
|
| Drug: Sevoflurane | Active Comparator | inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon | Drug | general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility/Safety of xenon anesthesia | assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation | Intraoperatively |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other secondary efficacy/safety measures | Perioperative blood loss | up to five days after surgery |
| Other secondary efficacy/safety measures | Requirement for blood (product) transfusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steffen Rex, PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26385664 | Derived | Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014978 | Xenon |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D005741 | Noble Gases |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D008738 |
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| sevoflurane |
| Drug |
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air |
|
assessed with the Confusion Assessment Method (CAM-ICU)
| up to five days after surgery |
| up to five days after surgery |
| Other secondary efficacy/safety measures | Duration of postoperative intensive care unit and hospital stay | until discharge from the hospital |
| Other secondary efficacy/safety measures | Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score | up to five days after surgery |
| Other secondary efficacy/safety measures | Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance | up to five days after surgery |
| other secondary efficacy/safety measures | Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II) | up to five days after surgery |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |