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NCT Number: NCT01285271

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

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.

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Key information

Conditions

Xenon Anesthetics, Inhalation Cardiovascular Diseases Coronary Artery Bypass Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sevoflurane Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation

Sevoflurane

Drug

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

Primary outcomes

  1. Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation

    Time frame: an average of 4 to 6 hours

    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

Secondary outcomes

  1. Secondary efficacy and safety criteria

    Time frame: 6 days

    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

  2. all cause mortality and contentment questioning

    Time frame: 1 year

    Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Acronym: CArDiAX

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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