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

Coronary Artery Disease Clinical Trial

Official title:

Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948765
• Other study ID #: SR022013
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2013
• Last updated: April 16, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal & Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative haemodynamic stability	Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption	intra-operative	Yes
Secondary	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	up to six months postoperative	Yes
Secondary	cerebrovascular accident not included in MACCE	cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)	up to six months postoperative	Yes
Secondary	postoperative renal function	postoperative renal function as assessed by serum creatinine and BUN levels)	up to five days postoperative	Yes
Secondary	requirement for blood(product) transfusion	requirement for blood(product) transfusion	up to five days postoperative	Yes
Secondary	length of stay	requirement for blood(product) transfusion	participants will be followed for the duration of hospital stay, an expected average of 10 days.	No
Secondary	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	up to five days postoperative	Yes
Secondary	incidence and duration of postoperative delirium	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	participants will be followed for the duration of hospital stay, an expectged average of 10 days	Yes
Secondary	incidence of further AE, SAE and SUSAR		participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes