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Completed

NCT Number: NCT01948765

Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.

The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.

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Key information

Conditions

Coronary Artery Disease Anesthesia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

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 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
  • COPD GOLD >II
  • Renal dysfunction defined as serum-creatinine >1.5mg/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, low preoperative cognitive state (MMSE at baseline <25), history of stroke with residuals, increased intracranial pressure
  • Hypersensitivity to the study medication
  • Presumed uncooperativeness or legal incapacity

Treatment and study plan

Xenon and propofol

Drug

xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)

Propofol

Drug

propofol target controlled infusion (target 1.5-2.5µg/ml)

Primary outcomes

  1. intraoperative haemodynamic stability

    Time frame: intra-operative

    Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption

Secondary outcomes

  1. MACCE (major adverse cardiac and cerebral events)

    Time frame: up to six months postoperative

    Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke

  2. cerebrovascular accident not included in MACCE

    Time frame: up to six months postoperative

    cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)

  3. postoperative renal function

    Time frame: up to five days postoperative

    postoperative renal function as assessed by serum creatinine and BUN levels)

  4. requirement for blood(product) transfusion

    Time frame: up to five days postoperative

    requirement for blood(product) transfusion

  5. length of stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days.

    requirement for blood(product) transfusion

  6. severity of postoperative critical illness

    Time frame: up to five days postoperative

    Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score

  7. incidence and duration of postoperative delirium

    Time frame: participants will be followed for the duration of hospital stay, an expectged average of 10 days

    incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination

  8. incidence of further AE, SAE and SUSAR

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 10 days

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Apr 17, 2015

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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