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Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing 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 and propofol
propofol
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, 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
  • COPD GOLD >II
  • Renal dysfunction defined as serum-creatinine >1.5mg/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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Xenon and propofol

propofol

Arm Description

Outcomes

Primary Outcome Measures

intraoperative haemodynamic stability
Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption

Secondary Outcome Measures

MACCE (major adverse cardiac and cerebral events)
Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke
cerebrovascular accident not included in MACCE
cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)
postoperative renal function
postoperative renal function as assessed by serum creatinine and BUN levels)
requirement for blood(product) transfusion
requirement for blood(product) transfusion
length of stay
requirement for blood(product) transfusion
severity of postoperative critical illness
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
incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination
incidence of further AE, SAE and SUSAR

Full Information

First Posted
August 8, 2013
Last Updated
April 16, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01948765
Brief Title
Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.
Official Title
Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 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
The investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.

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, Off-pump coronary artery bypass graft surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon and propofol
Arm Type
Active Comparator
Arm Title
propofol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Xenon and propofol
Intervention Description
xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
propofol target controlled infusion (target 1.5-2.5µg/ml)
Primary Outcome Measure Information:
Title
intraoperative haemodynamic stability
Description
Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
MACCE (major adverse cardiac and cerebral events)
Description
Death from any cause, perioperative life-threatening cardiac arrhythmias, perioperative myocardial infarction, requirement of surgical revisions at the coronary vessels, postoperative coronary angioplasty and stroke
Time Frame
up to six months postoperative
Title
cerebrovascular accident not included in MACCE
Description
cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)
Time Frame
up to six months postoperative
Title
postoperative renal function
Description
postoperative renal function as assessed by serum creatinine and BUN levels)
Time Frame
up to five days postoperative
Title
requirement for blood(product) transfusion
Description
requirement for blood(product) transfusion
Time Frame
up to five days postoperative
Title
length of stay
Description
requirement for blood(product) transfusion
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 days.
Title
severity of postoperative critical illness
Description
Severity of postoperative critical illness as indicated by the new simplified acute physiology score (SAPS II), SOFA and APACHE-II score
Time Frame
up to five days postoperative
Title
incidence and duration of postoperative delirium
Description
incidence and duration of postoperative delirium assessed with the Confusion Assessment Method (CAM-ICU), to be assessed in combination with the Mini Mental State Examination
Time Frame
participants will be followed for the duration of hospital stay, an expectged average of 10 days
Title
incidence of further AE, SAE and SUSAR
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 10 days

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 COPD GOLD >II Renal dysfunction defined as serum-creatinine >1.5mg/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
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
28598913
Citation
Al Tmimi L, Devroe S, Dewinter G, Van de Velde M, Poortmans G, Meyns B, Meuris B, Coburn M, Rex S. Xenon as an Adjuvant to Propofol Anesthesia in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery: A Pragmatic Randomized Controlled Clinical Trial. Anesth Analg. 2017 Oct;125(4):1118-1128. doi: 10.1213/ANE.0000000000002179.
Results Reference
derived

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Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.

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