Clinical trial NCT01948765: Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery.
Official title: Xenon as an Adjuvant to Propofol Anaesthesia in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery:a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Anesthesia
Keywords: xenon anesthesia
Off-pump coronary artery bypass graft surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: intraoperative haemodynamic stability
timeFrame: intra-operative
Secondary outcomes:
measure: MACCE (major adverse cardiac and cerebral events)
timeFrame: up to six months postoperative
measure: cerebrovascular accident not included in MACCE
timeFrame: up to six months postoperative
measure: postoperative renal function
timeFrame: up to five days postoperative
measure: requirement for blood(product) transfusion
timeFrame: up to five days postoperative
measure: length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days.
measure: severity of postoperative critical illness
timeFrame: up to five days postoperative
measure: incidence and duration of postoperative delirium
timeFrame: participants will be followed for the duration of hospital stay, an expectged average of 10 days
measure: incidence of further AE, SAE and SUSAR
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
citation: 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.