Clinical trial NCT01285271: A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon
Official title: The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Xenon
Sevoflurane
Anesthetics, Inhalation
Coronary Disease
Coronary Artery Bypass
Keywords: xenon
sevoflurane
cardiac anesthesia
CABG
Bypass surgery
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2011-01-27
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether xenon - as compared to sevoflurane - can be applied safely in patients for general anesthesia before and after CABG implantation.

Detailed description: The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anaesthesia for CABG surgery and will therefore necessarily be unblinded to the treatment conditions.

Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive xenon for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. Group 2 (Sevoflurane) will receive sevoflurane for maintenance of balanced anesthesia for CABG surgery before and after extracorporal circulation. During extracorporal circulation, general anesthesia will be maintained intravenously in both groups.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease scheduled for elective CABG
* Patients willing and able to complete the requirements of this study
* Ejection Fraction \> 50%
* EuroSCORE ≤ 8
* men and women \>= 50 yrs
* women without childbearing potential
* ASA Score II-IV

Exclusion Criteria:

* Lack of informed consent
* EuroSCORE \< 8
* MMSE \< 24
* Age \< 50 years
* COPD GOLD \> II, increased need of oxygen
* Renal dysfunction
* Liver function disorders
* Acute coronary syndrome during the last 24 hours; hemodynamic instability
* Requirement of inotropic support
* Off-pump-surgery
* Disabling neuropsychiatric disorders
* History of stroke with residuals
* Hypersensitivity to the study anaesthetics
* Increased intracranial pressure
* Pregnancy and lactation period
* Women of childbearing potential
* Presumed uncooperativeness or legal incapacity
* Participation in a concomitant trial

Primary outcomes:
measure: Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation
timeFrame: an average of 4 to 6 hours
Secondary outcomes:
measure: Secondary efficacy and safety criteria
timeFrame: 6 days
measure: all cause mortality and contentment questioning
timeFrame: 1 year
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Anesthesiology, University Hospital Aachen
state: NRW
Study officials:
affiliation: Department of Anesthesiology, University Hospital Aachen
name: Mark Coburn, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breuer T, Emontzpohl C, Coburn M, Benstoem C, Rossaint R, Marx G, Schalte G, Bernhagen J, Bruells CS, Goetzenich A, Stoppe C. Xenon triggers pro-inflammatory effects and suppresses the anti-inflammatory response compared to sevoflurane in patients undergoing cardiac surgery. Crit Care. 2015 Oct 15;19:365. doi: 10.1186/s13054-015-1082-7.
citation: Stoppe C, Fahlenkamp AV, Rex S, Veeck NC, Gozdowsky SC, Schalte G, Autschbach R, Rossaint R, Coburn M. Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study. Br J Anaesth. 2013 Sep;111(3):406-16. doi: 10.1093/bja/aet072. Epub 2013 Apr 11.