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

Phase 2CompletedNCT01948765

Universitaire Ziekenhuizen KU Leuven50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Coronary Artery Disease Anesthesia

Interventions

Xenon and propofolDRUG

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

propofolDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

intraoperative haemodynamic stability

Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption

Time frame: intra-operative

Secondary Outcomes

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

Time frame: up to six months postoperative

cerebrovascular accident not included in MACCE

cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)

Time frame: up to six months postoperative

postoperative renal function

postoperative renal function as assessed by serum creatinine and BUN levels)

Time frame: up to five days postoperative

requirement for blood(product) transfusion

Time frame: up to five days postoperative

length of stay

requirement for blood(product) transfusion

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

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

Time frame: up to five days postoperative

Data from ClinicalTrials.gov

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