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Sponsored by: |
Klinikum St. Georg gGmbH |
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Information provided by: | Klinikum St. Georg gGmbH |
ClinicalTrials.gov Identifier: | NCT00484796 |
Hypothesis: Trigeminus-evoked somatosensory potentials (TRI-SEP) may be used as an alternative technique to medianus-evoked somatosensory potentials (MED-SEP) in patients undergoing elective carotid surgery
Condition | Intervention |
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Carotid Surgery Neuromonitoring |
Procedure: MED-SEP Procedure: TRI-SEP Procedure: neuropsychological tests |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Comparison of Trigeminus-Evoked Somatosensory Potentials (TRI-SEP) and Medianus-Evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery |
Estimated Enrollment: | 120 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2009 |
Groups/Cohorts | Assigned Interventions |
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1
Patients undergoing carotid surgery
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Procedure: MED-SEP
intraoperative neuro-monitoring
Procedure: TRI-SEP
intraoperative neuro-monitoring
Procedure: neuropsychological tests
neurological short- and longterm outcome
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For CNS-monitoring somatosensory-evoked responses ba electrical stimulation of the contralateral median nerve are established: A reduction of amplitude and a delay in latency may represent a sensible marker of imminent cerebral ischemia. This study will evaluate a new concept by using trigeminal nerve evoked somatosensory evoked potentials in comparison to the established MED-SEP. Beside the comparison of two methods of neuromonitoring, this study will investigate the neurological long-term outcome (90-day evaluation) with different neuropsychological tests for the detection of cognitive deficits.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients undergoing carotid surgery
Inclusion Criteria:
Exclusion Criteria:
Contact: Armin R Sablotzki, MD | 0049-341-909-2570 | armin.sablotzki@sanktgeorg.de |
Contact: Michael Malcharek, MD | 0049-341-909-2570 | michael.malcharek@sanktgeorg.de |
Germany, Sachsen | |
Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy | Recruiting |
Leipzig, Sachsen, Germany, 04129 | |
Contact: Michael Malcharek, MD 0049-341-909-2570 michael.malcharek@sanktgeorg.de | |
Contact: Jeanette Landgraf 0049-341-909-2570 jeanette.landgraf@sanktgeorg.de | |
Sub-Investigator: Jeanette Landgraf | |
Sub-Investigator: Michael Malcharek, MD |
Principal Investigator: | Armin R Sablotzki, MD | Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy |
Responsible Party: | Klinikum St Georg Leipzig ( Armin Sablotzki, MD ) |
Study ID Numbers: | ISRCTN47041942, ISRCTN47041942 |
Study First Received: | June 8, 2007 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00484796 |
Health Authority: | Germany: Ethics Commission |
Carotid Surgery Cerebral Ischemia Cognitive Deficits Somatosensory-evoked Potentials |
Cerebral Infarction Brain Ischemia Ischemia |