NCT01948765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

August 8, 2013

Last Update Submit

April 16, 2015

Conditions

Coronary Artery DiseaseAnesthesia

Keywords

xenon anesthesiaOff-pump coronary artery bypass graft surgery

Outcome Measures

Primary Outcomes (1)

  • intraoperative haemodynamic stability

    Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption

    intra-operative

Secondary Outcomes (8)

  • MACCE (major adverse cardiac and cerebral events)

    up to six months postoperative

  • cerebrovascular accident not included in MACCE

    up to six months postoperative

  • postoperative renal function

    up to five days postoperative

  • requirement for blood(product) transfusion

    up to five days postoperative

  • length of stay

    participants will be followed for the duration of hospital stay, an expected average of 10 days.

  • +3 more secondary outcomes

Study Arms (2)

Xenon and propofol

ACTIVE COMPARATOR
Drug: Xenon and propofol

propofol

PLACEBO COMPARATOR
Drug: propofol

Interventions

Xenon and propofolDRUG

xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)

Xenon and propofol
propofolDRUG

propofol target controlled infusion (target 1.5-2.5µg/ml)

propofol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with coronary artery disease scheduled for elective OPCAB-surgery
  • patients willing and able to complete the requirements of this study
  • Ejection fraction \>30%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 28598913DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

XenonPropofol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Noble GasesElementsInorganic ChemicalsGasesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

August 8, 2013

First Posted

September 24, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

BE(1)