Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00484796

Acronym

TRISEP

Enrollment

120

Registered

2007-06-11

Start date

2006-10-31

Completion date

2012-02-29

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Surgery

Keywords

Carotid Surgery, Cerebral Ischemia, Cognitive Deficits, Somatosensory-evoked Potentials, Neuromonitoring

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.

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.

Interventions

PROCEDUREMED-SEP

intraoperative neurophysiological monitoring

PROCEDURETRI-SEP

intraoperative neurophysiologic monitoring

PROCEDUREneuropsychological tests

neurological short- and longterm outcome

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026