Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Phase 2

Completed

• Conditions: Coronary Artery Disease; Anesthesia
• Interventions: Drug: Xenon; Drug: sevoflurane

• Registration Number: NCT01757106
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-28
• Primary Completion: 2013-07
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Xenon	Xenon	gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery
Drug: Sevoflurane	sevoflurane	inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery

Primary Outcome Measures

Name	Time	Method
Feasibility/Safety of xenon anesthesia	Intraoperatively	assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebral events (MACCE)	up to six months after surgery	death from any cause; perioperative myocardial infarction and stroke
Incidence and duration of postoperative delirium	up to five days after surgery	assessed with the Confusion Assessment Method (CAM-ICU)

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium