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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Anesthesia
• Intervention / Treatment: Drug: Xenon and propofol; Drug: propofol

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: propofol	Drug: propofol; propofol target controlled infusion (target 1.5-2.5µg/ml)
Active Comparator: Xenon and propofol	Drug: Xenon and propofol; xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative haemodynamic stability	Haemodynamic stability as assessed by the individual intraoperative noradrenaline consumption	intra-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
cerebrovascular accident not included in MACCE	cerebrovascular accident not included in MACCE (TIA, reversible ischaemic neurologic deficit)	up to six months postoperative
postoperative renal function	postoperative renal function as assessed by serum creatinine and BUN levels)	up to five days postoperative
requirement for blood(product) transfusion	requirement for blood(product) transfusion	up to five days postoperative
length of stay	requirement for blood(product) transfusion	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	up to five days postoperative
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
incidence of further AE, SAE and SUSAR		participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 8, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 24, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: xenon anesthesia; Off-pump coronary artery bypass graft surgery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: SR022013