Xenon in Off-pump Coronary Artery Bypass Graft Surgery

NCT ID: NCT01757106

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-01-31

Brief Summary

Purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (OPCAB)-surgery is safe and feasible.

Detailed Description

The investigators hypothesize that xenon application during OPCAB-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. The evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events.

This study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (POD) following OPCAB-surgery and xenon treatment. POD is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. Xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of POD, as well as reducing other factors of perioperative organ injury including cardiac complications. Xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to POD.

Conditions

Coronary Artery Disease; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug: Xenon

gaseous anesthetic, dosage: 50-60% (v/v) in oxygen, continuous application during surgery

Group Type: EXPERIMENTAL

Xenon

Intervention Type: DRUG

general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)

Drug: Sevoflurane

inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application during surgery

Group Type: ACTIVE_COMPARATOR

sevoflurane

Intervention Type: DRUG

general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air

Interventions

Xenon

general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)

Intervention Type: DRUG

sevoflurane

general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air

Intervention Type: DRUG

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
• Pregnancy
• chronic obstructive pulmonary disease (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), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure
• Hypersensitivity to the study medication
• Presumed uncooperativeness or legal incapacity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

prof Dr Steffen Rex

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steffen Rex, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

University Hospitals Leuven

Leuven, , Belgium

Countries

Belgium

References

Al Tmimi L, Van Hemelrijck J, Van de Velde M, Sergeant P, Meyns B, Missant C, Jochmans I, Poesen K, Coburn M, Rex S. Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial. Br J Anaesth. 2015 Oct;115(4):550-9. doi: 10.1093/bja/aev303.

Reference Type: DERIVED

PMID: 26385664 (View on PubMed)

Other Identifiers

2012-002316-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SR052012

Identifier Type: -

Identifier Source: org_study_id