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: 12.1 Level: LLT Classification code 10002323 Term: Anesthesia general
Conditions
Interventions
Product Name: Xenon
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: XENON (133XE)
CAS Number: 14932-42-4
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentrat
Sponsors
Clinical Trials Center Aachen, University of Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: •Lack of informed consent •EuroSCORE > 8 •MMSE II and increased need of oxygen •Renal dysfunction defined as creatinine > 1.5 mg/dl or GFR 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: •Duration of postoperative intensive care unit (PACU) and in-hospital stay •Severity of postoperative critical illness •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 ;Primary end point(s): •level of depth of anaesthesia, •arterial and trans-cutaneous oxygen saturation •peri-operative haemodynamic profile | — |
Countries
Germany
Outcome results
None listed