Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.
NCT ID: NCT01948765
Last Updated: 2015-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2013-06-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Xenon and propofol
Xenon and propofol
xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
propofol
propofol
propofol target controlled infusion (target 1.5-2.5µg/ml)
Interventions
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Xenon and propofol
xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
propofol
propofol target controlled infusion (target 1.5-2.5µg/ml)
Eligibility Criteria
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Inclusion Criteria
* patients willing and able to complete the requirements of this study
* Ejection fraction \>30%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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prof Dr Steffen Rex
PhD, MD
Locations
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University Hospitals Leuven
Leuven, , Belgium
Countries
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References
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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.
Other Identifiers
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SR022013
Identifier Type: -
Identifier Source: org_study_id
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