ClinicalTrials.gov
ClinicalTrials.gov Menu

Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery (TRISEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00484796
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : October 29, 2012
Sponsor:
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Brief Summary:
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 or disease Intervention/treatment
Carotid Surgery Procedure: MED-SEP Procedure: TRI-SEP Procedure: neuropsychological tests

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.

Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery
Study Start Date : October 2006
Actual Primary Completion Date : June 2011
Actual Study Completion Date : February 2012

Group/Cohort Intervention/treatment
1
Patients undergoing carotid surgery
Procedure: MED-SEP
intraoperative neurophysiological monitoring

Procedure: TRI-SEP
intraoperative neurophysiologic monitoring

Procedure: neuropsychological tests
neurological short- and longterm outcome




Primary Outcome Measures :
  1. detection of episodes of cerebral ischemia during carotid surgery [ Time Frame: intraoperative, 28 days, and 60 days after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484796


Locations
Germany
Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
Leipzig, Sachsen, Germany, 04129
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

Responsible Party: Armin Sablotzki, MD, Prof. Dr. med., Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier: NCT00484796     History of Changes
Other Study ID Numbers: ISRCTN47041942
ISRCTN47041942
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: October 29, 2012
Last Verified: October 2012

Keywords provided by Armin Sablotzki, MD, Klinikum St. Georg gGmbH:
Carotid Surgery
Cerebral Ischemia
Cognitive Deficits
Somatosensory-evoked Potentials
Neuromonitoring