The use of Xenon-gas (anesthesia), as an adjuvant to propofol anaesthesia, to patients who are undergoing an off-pump (heart keeps beating on its own) bypass of the coronary artery: a randomized controlled trial

Xenon as an adjuvant to propofol anaesthesia in patients undergoing off-pump coronary artery bypass graft surgery: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000485-11-BE

Enrollment

Registered

2013-03-20

Start date

2013-04-24

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xenon anesthesia in cardiac surgery

Interventions

Trade Name: Xenon Product Name: Xenon Pharmaceutical Form: Inhalation vapour INN or Proposed INN: Xenon CAS Number: 7440-63-3 Other descriptive name: XENON Concentration unit: % (V/V) percent volume/v

Eligibility

Sex/Gender

All

Inclusion criteria

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% 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: • Lack of informed consent • Age 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), 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this study is to assess whether the administration of xenon as an adjuvant to propofol anesthesia is superior to anesthesia with propofol alone in patients undergoing off-pump coronary artery bypass surgery.;Secondary Objective: Evaluation of: • MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions at the coronary vessels; postoperative coronary angioplasty; and stroke. • Any cerebrovascular accident not included in MACCE (transient ischemic attacks, reversible ischaemic neurologic deficit) • Postoperative renal function • Requirement for blood (product) transfusion • Any complication occurring in the early postoperative period and not mentioned above (i.e., wound infection, bleeding) • Duration of postoperative intensive care unit and hospital stay • Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score • Incidence and duration of postoperative delirium assessed with the Confusion Assessment Method to be assessed in combination with the Mini Mental State Examination ;Primary end point(s): Intraoperative haemodynamic stability, as assessed by the individual intraoperative noradrenaline consumption, normalized for body weight and duration of the surgical procedure;Timepoint(s) of evaluation of this end point: - hemodynamic parameters every 5 min during the operative phase; - once daily untill postoperative day 5	—

Measure

Time frame

Main Objective: The aim of this study is to assess whether the administration of xenon as an adjuvant to propofol anesthesia is superior to anesthesia with propofol alone in patients undergoing off-pump coronary artery bypass surgery.;Secondary Objective: Evaluation of: • MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions at the coronary vessels; postoperative coronary angioplasty; and stroke. • Any cerebrovascular accident not included in MACCE (transient ischemic attacks, reversible ischaemic neurologic deficit) • Postoperative renal function • Requirement for blood (product) transfusion • Any complication occurring in the early postoperative period and not mentioned above (i.e., wound infection, bleeding) • Duration of postoperative intensive care unit and hospital stay • Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score • Incidence and duration of postoperative delirium assessed with the Confusion Assessment Method to be assessed in combination with the Mini Mental State Examination ;Primary end point(s): Intraoperative haemodynamic stability, as assessed by the individual intraoperative noradrenaline consumption, normalized for body weight and duration of the surgical procedure;Timepoint(s) of evaluation of this end point: - hemodynamic parameters every 5 min during the operative phase; - once daily untill postoperative day 5

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Secondary

Measure	Time frame
Secondary end point(s): MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions at the coronary vessels; postoperative coronary angioplasty; and stroke. • Any cerebrovascular accident not included in MACCE (transient ischemic attacks, reversible ischaemic neurologic deficit) • Postoperative renal function • Requirement for blood (product) transfusion • Any complication occurring in the early postoperative period and not mentioned above (i.e., wound infection, bleeding) • Duration of postoperative intensive care unit and hospital stay • Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score • Incidence and duration of postoperative delirium assessed with the Confusion Assessment Method to be assessed in combination with the Mini Mental State Examination ;Timepoint(s) of evaluation of this end point: Daily untill at least postoperative day 5 Day before discharge telephone call 6 months after discharge from the hospital.	—

Measure

Time frame

Secondary end point(s): MACCE (major adverse cardiac and cerebral events, i.e. death from any cause; perioperative myocardial infarction (occurring until discharge from hospital); requirement of surgical revisions at the coronary vessels; postoperative coronary angioplasty; and stroke. • Any cerebrovascular accident not included in MACCE (transient ischemic attacks, reversible ischaemic neurologic deficit) • Postoperative renal function • Requirement for blood (product) transfusion • Any complication occurring in the early postoperative period and not mentioned above (i.e., wound infection, bleeding) • Duration of postoperative intensive care unit and hospital stay • Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score • Incidence and duration of postoperative delirium assessed with the Confusion Assessment Method to be assessed in combination with the Mini Mental State Examination ;Timepoint(s) of evaluation of this end point: Daily untill at least postoperative day 5 Day before discharge telephone call 6 months after discharge from the hospital.

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Countries

Belgium

Contacts

Public ContactAnesthesia Research

University Hospitals of the KU Leuven

christel.huygens@uzleuven.be003216344620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026