NCT01285271

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

The Safety and Feasibility of Delivering Xenon to Patients Before and After Coronary Artery Bypass Graft Implantation: a Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xenon
• Sevoflurane
• Anesthetics, Inhalation
• Coronary Disease
• Coronary Artery Bypass

Interventions

Type	Name	Description
DRUG	Xenon	gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
DRUG	Sevoflurane	inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-01-27
• Last updated: 2011-10-06

Locations

1 site across 1 country: Germany