Clinical trial NCT01757106: Xenon in Off-pump Coronary Artery Bypass Graft Surgery
Official title: The Safety and Feasibility of Administering Xenon to Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Anesthesia
Keywords: xenon anesthesia
sevoflurane anesthesia
off-pump coronary artery bypass graft surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-12-28
Enrollment: 42
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: 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.

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

Primary outcomes:
measure: Feasibility/Safety of xenon anesthesia
timeFrame: Intraoperatively
Secondary outcomes:
measure: Major adverse cardiac and cerebral events (MACCE)
timeFrame: up to six months after surgery
measure: Incidence and duration of postoperative delirium
timeFrame: up to five days after surgery
Other outcomes:
measure: Other secondary efficacy/safety measures
timeFrame: up to five days after surgery
measure: Other secondary efficacy/safety measures
timeFrame: up to five days after surgery
measure: Other secondary efficacy/safety measures
timeFrame: until discharge from the hospital
measure: Other secondary efficacy/safety measures
timeFrame: up to five days after surgery
measure: Other secondary efficacy/safety measures
timeFrame: up to five days after surgery
measure: other secondary efficacy/safety measures
timeFrame: up to five days after surgery
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: UZ Leuven
name: Steffen Rex, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.