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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armin Sablotzki, MD, Klinikum St. Georg gGmbH
ClinicalTrials.gov Identifier:
NCT00484796
First received: June 8, 2007
Last updated: October 26, 2012
Last verified: October 2012
  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
Procedure: MED-SEP
Procedure: TRI-SEP
Procedure: neuropsychological tests

Study Type: Observational
Study Design: 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

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 ]

Enrollment: 120
Study Start Date: October 2006
Study Completion Date: February 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: June 8, 2007
Last Updated: October 26, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 20, 2014