Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Universitaire Ziekenhuizen KU Leuven

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Anesthesia

Treatments

Drug: sevoflurane

Drug: Xenon

Study type

Interventional

Funder types

Other

Identifiers

NCT01757106

SR052012

2012-002316-12 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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