Skip to main content
OpenTrials
Completed

NCT Number: NCT00484796

Trigeminus-evoked Somatosensory Potentials 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carotid Surgery Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Mental Disorders Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Leipzig, Saxony, 04129, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED-SEP

Procedure

intraoperative neurophysiological monitoring

TRI-SEP

Procedure

intraoperative neurophysiologic monitoring

neuropsychological tests

Procedure

neurological short- and longterm outcome

Primary outcomes

  1. detection of episodes of cerebral ischemia during carotid surgery

    Time frame: intraoperative, 28 days, and 60 days after surgery

Sponsors and collaborators

Lead sponsor

Klinikum St. Georg gGmbH

Other

Registry information

Official study title

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

Acronym: TRISEP

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Jun 11, 2007
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.