Brief Title
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
Official Title
Near Infrared Spectroscopy in Aortic Valve Replacement
Brief Summary
Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods. This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.
Study Type
Interventional
Primary Outcome
Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural
Condition
Aortic Valve Stenosis
Intervention
General anaesthesia
Study Arms / Comparison Groups
General anaesthesia
Description: General anaesthesia is performed under standardized conditions
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
62
Start Date
December 2010
Completion Date
April 2012
Primary Completion Date
April 2012
Eligibility Criteria
Inclusion Criteria: - informed consent - transcatheter aortic valve implantation Exclusion Criteria: - denial by patient - denial by screening anaesthesist - active neurodegenerative disease
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Patrick N Mayr, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01251328
Organization ID
GE DHM-AN-OR-2010/01
Responsible Party
Principal Investigator
Study Sponsor
Deutsches Herzzentrum Muenchen
Study Sponsor
Patrick N Mayr, MD, Principal Investigator, Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
Verification Date
February 2015