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Xenon in Off-pump Coronary Artery Bypass Graft Surgery

Primary Purpose

Coronary Artery Disease, Anesthesia

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Xenon
sevoflurane
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug: Xenon

Drug: Sevoflurane

Arm Description

gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery

Outcomes

Primary Outcome Measures

Feasibility/Safety of xenon anesthesia
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation

Secondary Outcome Measures

Major adverse cardiac and cerebral events (MACCE)
death from any cause; perioperative myocardial infarction and stroke
Incidence and duration of postoperative delirium
assessed with the Confusion Assessment Method (CAM-ICU)

Full Information

First Posted
December 3, 2012
Last Updated
March 24, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01757106
Brief Title
Xenon in Off-pump Coronary Artery Bypass Graft Surgery
Official Title
The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anesthesia
Keywords
xenon anesthesia, sevoflurane anesthesia, off-pump coronary artery bypass graft surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Xenon
Arm Type
Experimental
Arm Description
gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery
Arm Title
Drug: Sevoflurane
Arm Type
Active Comparator
Arm Description
inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
Primary Outcome Measure Information:
Title
Feasibility/Safety of xenon anesthesia
Description
assessed by: depth of anesthesia, perioperative hemodynamic profile, peripheral and arterial oxygen saturation
Time Frame
Intraoperatively
Secondary Outcome Measure Information:
Title
Major adverse cardiac and cerebral events (MACCE)
Description
death from any cause; perioperative myocardial infarction and stroke
Time Frame
up to six months after surgery
Title
Incidence and duration of postoperative delirium
Description
assessed with the Confusion Assessment Method (CAM-ICU)
Time Frame
up to five days after surgery
Other Pre-specified Outcome Measures:
Title
Other secondary efficacy/safety measures
Description
Perioperative blood loss
Time Frame
up to five days after surgery
Title
Other secondary efficacy/safety measures
Description
Requirement for blood (product) transfusion
Time Frame
up to five days after surgery
Title
Other secondary efficacy/safety measures
Description
Duration of postoperative intensive care unit and hospital stay
Time Frame
until discharge from the hospital
Title
Other secondary efficacy/safety measures
Description
Severity of postoperative critical illness as indicated by the sequential organ failure assessment (SOFA) score
Time Frame
up to five days after surgery
Title
Other secondary efficacy/safety measures
Description
Perioperative renal function assessed by serum-creatinine levels and calculated creatinine clearance
Time Frame
up to five days after surgery
Title
other secondary efficacy/safety measures
Description
Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II)
Time Frame
up to five days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Rex, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
26385664
Citation
Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303.
Results Reference
derived

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Xenon in Off-pump Coronary Artery Bypass Graft Surgery

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