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ISRCTN
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ISRCTN47041942
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ClinicalTrials.gov identifier
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NCT00484796
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Public title
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Comparison of TRIgemus-evoked SomatosEnsory Potentials and medianus-evoked somatosensory potentials in patients undergoing carotid surgery
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Scientific title
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Acronym
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TRI-SEP-Study
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Serial number at source
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EK-BR-22/06-1
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Study hypothesis
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Trigemus-evoked Somatosensory Potentials (TRI-SEP) may be used as an alternative to Medianus-evoked Somatosensory Potentials (MED-SEP) for the detection of cerebral ischaemic events during elective carotid surgery.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approval by the Ethics Committee of the Saxonian Chamber of Physicians (Ref-Nr: EK-BR-22/0-1).
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Study design
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Prospective, open, clinical study.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Detection of cerebral ischaemic events during elective carotid surgery
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Participants - inclusion criteria
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1. Aged over 18 years
2. Agreemant with study procedures and informed consent
3. Elective carotid surgery
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Participants - exclusion criteria
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1. Inability to take somatosensory potentials
2. Inability to respond to the cognitive tests
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Anticipated start date
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15/09/2006
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Anticipated end date
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31/12/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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This study will compare the validity of both methods to detect cerebral ischaemic events, therefore in all patients Medianus- (MED-SEP) and Trigeminus- (TRI-SEP) evoked somatosensory potentials were taken during elective carotid surgery. The cognitive tests were taken in all patients preoperatively and in the early postoperative course to document the cognitive function and detect cognitive disorders.
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Primary outcome measure(s)
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Cerebral ischaemic events during elective carotid surgery
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Secondary outcome measure(s)
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Results of cognitive tests
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Sources of funding
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This study is funded by our institution: Clinics of Anesthesiology, Critical Care and Pain Therapy
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20965778
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Contact name
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Dr
Malcharek
Michael
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Address
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Klinikum St. Georg gGmbH
Clinics of Anaesthesiology
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
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City/town
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Leipzig
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Zip/Postcode
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04105
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Country
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Germany
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Tel
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+49 (0)341 909 2570
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Fax
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+49 (0)341 909 2568
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Email
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michael.malcharek@sanktgeorg.de
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Sponsor
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Klinikum St. Georg gGmbH (Germany)
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Address
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Clinic of Anaesthesia
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
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City/town
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Leipzig
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Zip/Postcode
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04105
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Country
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Germany
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Tel
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+49 (0)341 909 2570
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Fax
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+49 (0)341 909 2568
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Email
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kais@sanktgeorg.de
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Sponsor website:
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http://www.sanktgeorg.de
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Date applied
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31/08/2006
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Last edited
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04/07/2011
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Date ISRCTN assigned
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21/09/2006
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