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

October 26, 2012 updated by: Armin Sablotzki, MD, Klinikum St. Georg gGmbH

Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing carotid surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
detection of episodes of cerebral ischemia during carotid surgery
Time Frame: intraoperative, 28 days, and 60 days after surgery
intraoperative, 28 days, and 60 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum St. Georg gGmbH

Investigators

  • Principal Investigator: Armin R Sablotzki, MD, Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ISRCTN47041942

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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