The safety and feasibility of delivering xenon to patients before and after coronary artery bypass graft implantation: a pilot studyAbbreviated study title:A pre- and post-Coronary Artery bypass graft implantation Disposed Application of Xenon – CArDiAX - CArDiAX

Conditions: The aim of this study is to determine whether xenon and remifentanil – as compared to sevoflurane and remifentanil – can be applied safely in patients after CABG implantation for the remaining surgery time.
MedDRA version: 12.1Level: LLTClassification code 10002323Term: Anesthesia general

Registration Number: EUCTR2010-023942-63-DE

Lead Sponsor: Clinical Trials Center Aachen, University of Aachen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Patients with coronary artery disease scheduled for elective CABG
•Patients willing and able to complete the requirements of this study
•Ejection Fraction > 50%
•EuroSCORE = 8
•men and women > 50 yrs
•if women, then without childbearing potential, i.e. hysterectomy, sterilization, post-menopausal (late of last menses > 2 yrs ago)
•ASA Score II-IV
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Lack of informed consent
•EuroSCORE > 8
•MMSE < 24
•Age < 50 years
•COPD GOLD > II and increased need of oxygen
•Renal dysfunction defined as creatinine > 1.5 mg/dl or GFR < 60 ml/min (stadium NKF = III)
•Liver function disorders (Liver enzymes > twice the upper limit)
•Acute coronary syndrome during the last 24 hours; hemodynamic instability
•requirement of inotropic support
•Off-pump-surgery
•Disabling neuropsychiatric disorders (severe dementia, Alzheimer’s disease, schizophrenia, depression)
•History of stroke with residuals
•increased intracranial pressure
•Hypersensitivity to the study anaesthetics
•pregnancy and lactation period
•women of childbearing potential
•Presumed uncooperativeness or legal incapacity
•participation in a concomitant trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to determine whether xenon and remifentanil – as compared to sevoflurane and remifentanil – can be applied safely in patients after CABG implantation for the remaining surgery time.;Secondary Objective: The secondary objectives of this study are: <br>•Duration of postoperative intensive care unit (PACU) and in-hospital stay <br>•Severity of postoperative critical illness<br>•The incidence of POD between xenon and sevoflurane treatment as pilot work for a following multi-centre randomized controlled trial assessing the incidence of post-operative delirium anaesthesia in patients obtaining CABG surgery <br>;Primary end point(s): •level of depth of anaesthesia, <br>•arterial and trans-cutaneous oxygen saturation<br>•peri-operative haemodynamic profile<br>

Secondary Outcome Measures