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Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

NCT ID: NCT00484796

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carotid Surgery

Keywords

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Carotid Surgery Cerebral Ischemia Cognitive Deficits Somatosensory-evoked Potentials Neuromonitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients undergoing carotid surgery

MED-SEP

Intervention Type PROCEDURE

intraoperative neurophysiological monitoring

TRI-SEP

Intervention Type PROCEDURE

intraoperative neurophysiologic monitoring

neuropsychological tests

Intervention Type PROCEDURE

neurological short- and longterm outcome

Interventions

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MED-SEP

intraoperative neurophysiological monitoring

Intervention Type PROCEDURE

TRI-SEP

intraoperative neurophysiologic monitoring

Intervention Type PROCEDURE

neuropsychological tests

neurological short- and longterm outcome

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \>= 18 years
* Agreement with study procedure
* Elective carotid surgery

Exclusion Criteria

* Inability to take somatosensory potentials
* Inability to respond to neuropsychological tests
* Severe preoperative neurological deficit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum St. Georg gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Armin Sablotzki, MD

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Armin R Sablotzki, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy

Locations

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Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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ISRCTN47041942

Identifier Type: -

Identifier Source: secondary_id

ISRCTN47041942

Identifier Type: -

Identifier Source: org_study_id