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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Anesthesia

Treatments: Drug: propofol; Drug: Xenon and propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01948765

SR022013

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Xenon and propofol

Active Comparator group

Treatment:

Drug: Xenon and propofol

propofol

Placebo Comparator group

Treatment:

Drug: propofol