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Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT01757106
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
13
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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)
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

Outcome Measures

Primary Outcome Measures

  1. Feasibility/Safety of xenon anesthesia [Intraoperatively]

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

Secondary Outcome Measures

  1. Major adverse cardiac and cerebral events (MACCE) [up to six months after surgery]

    death from any cause; perioperative myocardial infarction and stroke

  2. Incidence and duration of postoperative delirium [up to five days after surgery]

    assessed with the Confusion Assessment Method (CAM-ICU)

Other Outcome Measures

  1. Other secondary efficacy/safety measures [up to five days after surgery]

    Perioperative blood loss

  2. Other secondary efficacy/safety measures [up to five days after surgery]

    Requirement for blood (product) transfusion

  3. Other secondary efficacy/safety measures [until discharge from the hospital]

    Duration of postoperative intensive care unit and hospital stay

  4. Other secondary efficacy/safety measures [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 [up to five days after surgery]

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

  6. other secondary efficacy/safety measures [up to five days after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University Hospitals Leuven Leuven Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Steffen Rex, PhD, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
prof Dr Steffen Rex, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01757106
Other Study ID Numbers:
  • SR052012
  • 2012-002316-12
First Posted:
Dec 28, 2012
Last Update Posted:
Mar 26, 2014
Last Verified:
Mar 1, 2014
Keywords provided by prof Dr Steffen Rex, Prof. Dr., Universitaire Ziekenhuizen Leuven
xenon anesthesia
sevoflurane anesthesia
off-pump coronary artery bypass graft surgery
Additional relevant MeSH terms:
Coronary Artery Disease
Sevoflurane

Study Results

No Results Posted as of Mar 26, 2014