Xenon in Off-pump Coronary Artery Bypass Graft Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
prof Dr Steffen Rex, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01757106
First received: December 3, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Anesthesia
Drug: Xenon
Drug: sevoflurane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Feasibility/Safety of xenon anesthesia [ Time Frame: Intraoperatively ] [ Designated as safety issue: Yes ]
    assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation


Secondary Outcome Measures:
  • Major adverse cardiac and cerebral events (MACCE) [ Time Frame: up to six months after surgery ] [ Designated as safety issue: Yes ]
    death from any cause; perioperative myocardial infarction and stroke

  • Incidence and duration of postoperative delirium [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]
    assessed with the Confusion Assessment Method (CAM-ICU)


Other Outcome Measures:
  • Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]
    Perioperative blood loss

  • Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]
    Requirement for blood (product) transfusion

  • Other secondary efficacy/safety measures [ Time Frame: until discharge from the hospital ] [ Designated as safety issue: No ]
    Duration of postoperative intensive care unit and hospital stay

  • Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]
    Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score

  • Other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: Yes ]
    Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance

  • other secondary efficacy/safety measures [ Time Frame: up to five days after surgery ] [ Designated as safety issue: No ]
    Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)


Enrollment: 42
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Xenon
gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery
Drug: Xenon
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
Other Name: Xenon
Active Comparator: Drug: Sevoflurane
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery
Drug: sevoflurane
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
Other Name: sevoflurane

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757106

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Steffen Rex, PhD UZ Leuven
  More Information

No publications provided

Responsible Party: prof Dr Steffen Rex, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01757106     History of Changes
Other Study ID Numbers: SR052012, 2012-002316-12
Study First Received: December 3, 2012
Last Updated: March 24, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:
xenon anesthesia
sevoflurane anesthesia
off-pump coronary artery bypass graft surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Xenon
Sevoflurane
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014