A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon

Phase 3

Completed

• Conditions: Xenon; Sevoflurane; Anesthetics, Inhalation; Coronary Disease; Coronary Artery Bypass
• Interventions: Drug: Xenon; Drug: Sevoflurane

• Registration Number: NCT01285271
• Lead Sponsor: RWTH Aachen University

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.

Study Timeline

• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xenon	Xenon	Xenon will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.
Sevoflurane	Sevoflurane	Sevoflurane will be administered for balanced general anesthesia for CABG surgery before and after the extracorporal circulation.

Primary Outcome Measures

Name	Time	Method
Evaluation of the safety and feasibility of xenon application for general anesthesia before and after CABG implantation	an average of 4 to 6 hours	The feasibility of xenon application compared to sevoflurane application will be assessed by: * The depth of anaesthesia level; * The peri-anaesthetic respiratory profile; * The peri-anaesthetic haemodynamic profile; The following safety parameters will be assessed: * Doses and concentration of study treatments; * Trans-esophageal echocardiography; * Measures of renal function; * Intra-operative blood loss and amount of transfused blood/products; * Need for hemodynamic and inotropic support; * The patient's regional cerebral tissue oxygenation rSO2; * The incidence of AE and SAE

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy and safety criteria	6 days	The following secondary efficacy parameters will be assessed: * the patients organ function status; * The severity of postoperative critical illness; * The incidence of Post-operative Delirium (POD); * The duration of postoperative intensive care unit and in-hospital stay; Secondary safety parameters: * hemodynamic and respiratory profile, including vital signs; * incidence of major adverse cardiac and cerebral events (MACCE); * laboratory parameters -post-operative pain; * further AE and SAE
all cause mortality and contentment questioning	1 year	Patients will be contacted by telephone one year after surgery for a one year mortality and contentment examination.

Trial Locations

Locations (1)

Department of Anesthesiology, University Hospital Aachen; 🇩🇪 Aachen, NRW, Germany