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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Xenon and propofol

Group Type ACTIVE_COMPARATOR

Xenon and propofol

Intervention Type DRUG

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

propofol

Group Type PLACEBO_COMPARATOR

propofol

Intervention Type DRUG

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)

Intervention Type DRUG

propofol

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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prof Dr Steffen Rex

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

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.

Reference Type DERIVED
PMID: 28598913 (View on PubMed)

Other Identifiers

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SR022013

Identifier Type: -

Identifier Source: org_study_id

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