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

Phase 2

Completed

• Conditions: Coronary Artery Disease; Anesthesia
• Interventions: Drug: Xenon and propofol; Drug: propofol

• Registration Number: NCT01948765
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-09-18
• Study First Posted: 2013-09-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenon and propofol	Xenon and propofol	-
propofol	propofol	-

Primary Outcome Measures

Name	Time	Method
intraoperative haemodynamic stability	intra-operative	Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption

Secondary Outcome Measures

Name	Time	Method
MACCE (major adverse cardiac and cerebral events)	up to six months postoperative	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	up to six months postoperative	cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)
postoperative renal function	up to five days postoperative	postoperative renal function as assessed by serum creatinine and BUN levels)
requirement for blood(product) transfusion	up to five days postoperative	requirement for blood(product) transfusion
length of stay	participants will be followed for the duration of hospital stay, an expected average of 10 days.	requirement for blood(product) transfusion
severity of postoperative critical illness	up to five days postoperative	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	participants will be followed for the duration of hospital stay, an expectged average of 10 days	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	participants will be followed for the duration of hospital stay, an expected average of 10 days

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium