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Completed

NCT Number: NCT01757106

Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

About this study

The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events.

This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.

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
  • Pregnancy
  • chronic obstructive pulmonary disease (COPD) GOLD > II
  • Renal dysfunction defined as serum-creatinine > 1.5 mg/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), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure
  • Hypersensitivity to the study medication
  • Presumed uncooperativeness or legal incapacity

Treatment and study plan

Xenon

Drug

general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)

Sevoflurane

Drug

general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air

Primary outcomes

  1. Feasibility/Safety of xenon anesthesia

    Time frame: Intraoperatively

    assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation

Secondary outcomes

  1. Major adverse cardiac and cerebral events (MACCE)

    Time frame: up to six months after surgery

    death from any cause; perioperative myocardial infarction and stroke

  2. Incidence and duration of postoperative delirium

    Time frame: up to five days after surgery

    assessed with the Confusion Assessment Method (CAM-ICU)

Other outcomes

  1. Other secondary efficacy/safety measures

    Time frame: up to five days after surgery

    Perioperative blood loss

  2. Other secondary efficacy/safety measures

    Time frame: up to five days after surgery

    Requirement for blood (product) transfusion

  3. Other secondary efficacy/safety measures

    Time frame: until discharge from the hospital

    Duration of postoperative intensive care unit and hospital stay

  4. Other secondary efficacy/safety measures

    Time frame: up to five days after surgery

    Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score

  5. Other secondary efficacy/safety measures

    Time frame: up to five days after surgery

    Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance

  6. other secondary efficacy/safety measures

    Time frame: up to five days after surgery

    Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Dec 28, 2012
Registry last updated
Mar 26, 2014

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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