Trigeminus-Evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery - Full Text View

Sponsored by:	Klinikum St. Georg gGmbH
Information provided by:	Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:	NCT00484796

Purpose

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
Carotid Surgery Neuromonitoring	Procedure: MED-SEP Procedure: TRI-SEP Procedure: neuropsychological tests

U.S. FDA Resources

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

Further study details as provided by Klinikum St. Georg gGmbH:

Primary Outcome Measures:

detection of episodes of cerebral ischemia during carotid surgery [ Time Frame: intraoperative, 28 days, and 60 days after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2009

Groups/Cohorts	Assigned Interventions
1 Patients undergoing carotid surgery	Procedure: MED-SEP intraoperative neuro-monitoring Procedure: TRI-SEP intraoperative neuro-monitoring Procedure: neuropsychological tests neurological short- and longterm outcome

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients undergoing carotid surgery

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484796

Contacts

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

Locations

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

Sponsors and Collaborators

Klinikum St. Georg gGmbH

Investigators

Principal Investigator:

Armin R Sablotzki, MD

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

More Information

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

Keywords provided by Klinikum St. Georg gGmbH:

Carotid Surgery
Cerebral Ischemia
Cognitive Deficits
Somatosensory-evoked Potentials

Study placed in the following topic categories:

Cerebral Infarction
Brain Ischemia
Ischemia

ClinicalTrials.gov processed this record on January 16, 2009