A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon (CArDiAX)

The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study

The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Coronary Artery Bypass; Xenon; Sevoflurane; Anesthetics, Inhalation
• Intervention / Treatment: Drug: Xenon; Drug: Sevoflurane

Detailed Description

The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.

Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • Department of Anesthesiology, University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• women without childbearing potential
• ASA Score II-IV

Exclusion Criteria:

• Lack of informed consent
• EuroSCORE < 8
• MMSE < 24
• Age < 50 years
• COPD GOLD > II, increased need of oxygen
• Renal dysfunction
• Liver function disorders
• Acute coronary syndrome during the last 24 hours; hemodynamic instability
• Requirement of inotropic support
• Off-pump-surgery
• Disabling neuropsychiatric disorders
• History of stroke with residuals
• Hypersensitivity to the study anaesthetics
• Increased intracranial pressure
• Pregnancy and lactation period
• Women of childbearing potential
• Presumed uncooperativeness or legal incapacity
• Participation in a concomitant trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xenon; Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.	Drug: Xenon; gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
Active Comparator: Sevoflurane; Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.	Drug: Sevoflurane; inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation	The feasibility of xenon application compared to sevoflurane application will be assessed by: The depth of anaesthesia level; The peri-anaesthetic respiratory profile; The peri-anaesthetic haemodynamic profile The following safety parameters will be assessed: Doses and concentration of study treatments; Trans-esophageal echocardiography; Measures of renal function; Intra-operative blood loss and amount of transfused blood/products; Need for hemodynamic and inotropic support; The patient's regional cerebral tissue oxygenation rSO2; The incidence of AE and SAE	an average of 4 to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy and safety criteria	The following secondary efficacy parameters will be assessed: the patients organ function status; The severity of postoperative critical illness; The incidence of Post-operative Delirium (POD); The duration of postoperative intensive care unit and in-hospital stay Secondary safety parameters: hemodynamic and respiratory profile, including vital signs; incidence of major adverse cardiac and cerebral events (MACCE); laboratory parameters -post-operative pain; further AE and SAE	6 days
all cause mortality and contentment questioning	Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.	1 year

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Mark Coburn, PD Dr. med., Department of Anesthesiology, University Hospital Aachen

Publications and helpful links

General Publications

• Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.
• Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: sevoflurane; xenon; cardiac anesthesia; CABG; Bypass surgery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 10-017; 2010-023942-63 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No