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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anaesthesia | Active Comparator | General anaesthesia is performed under standardized conditions |
|
| Sedation | Active Comparator | Sedation is performed under standardized conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anaesthesia | Procedure | general anaesthesia is performed according to the hospitals standard |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural | Biomarkers for cerebral ischemia will be measured up to 48 hours | up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick N Mayr, MD | Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum München | Munich | Bavaria | D-80636 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26424178 | Derived | Mayr NP, Hapfelmeier A, Martin K, Kurz A, van der Starre P, Babik B, Mazzitelli D, Lange R, Wiesner G, Tassani-Prell P. Comparison of sedation and general anaesthesia for transcatheter aortic valve implantation on cerebral oxygen saturation and neurocognitive outcomedagger. Br J Anaesth. 2016 Jan;116(1):90-9. doi: 10.1093/bja/aev294. Epub 2015 Sep 29. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Sedation | Procedure | Sedation is performed according to the hospitals standard |
|
| D014694 |
| Ventricular Outflow Obstruction |