The use of Xenon-gas (anesthesia), as an adjuvant to propofol anaesthesia, to patients who are undergoing an off-pump (heart keeps beating on its own) bypass of the coronary artery: a randomized controlled trial

Phase 1

• Conditions: Xenon anesthesia in cardiac surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-000485-11-BE
• Lead Sponsor: niversity Hospitals of the KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-20
• Study Completion: 2014-12-01
• Last Update Posted: 30 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• 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%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Lack of informed consent
•Age < 18 years
•Pregnancy
•COPD GOLD > II
•Renal dysfunction defined as serum-creatinine > 1.5 mg/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 clinical trial of medicinal product
• Study Design: Not specified