Xenon in Off-pump Coronary Artery Bypass Graft Surgery
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Purpose
Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Anesthesia |
Drug: Xenon Drug: sevoflurane |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study |
- Feasibility/Safety of xenon anesthesia [ Time Frame: Intraoperatively ] [ Designated as safety issue: Yes ]assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
- Major adverse cardiac and cerebral events (MACCE) [ Time Frame: up to six months after surgery ] [ Designated as safety issue: Yes ]death from any cause; perioperative myocardial infarction and stroke
- Incidence and duration of postoperative delirium [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]assessed with the Confusion Assessment Method (CAM-ICU)
- Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]Perioperative blood loss
- Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]Requirement for blood (product) transfusion
- Other secondary efficacy/safety measures [ Time Frame: until discharge from the hospital ] [ Designated as safety issue: No ]Duration of postoperative intensive care unit and hospital stay
- Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score
- Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance
- other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: No ]Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Drug: Xenon
gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery
|
Drug: Xenon
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
Other Name: Xenon
|
|
Active Comparator: Drug: Sevoflurane
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery
|
Drug: sevoflurane
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
Other Name: sevoflurane
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | prof Dr Steffen Rex, Prof. Dr., Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01757106 History of Changes |
| Other Study ID Numbers: | SR052012, 2012-002316-12 |
| Study First Received: | December 3, 2012 |
| Last Updated: | May 30, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
xenon anesthesia sevoflurane anesthesia off-pump coronary artery bypass graft surgery |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Xenon Sevoflurane |
Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on June 17, 2013