Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

Carotid Surgery Clinical Trial

— TRISEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484796
• Other study ID #: ISRCTN47041942
• Secondary ID: ISRCTN47041942
• Status: Completed
• Phase: N/A
• First received: June 8, 2007
• Last updated: October 26, 2012
• Start date: October 2006
• Est. completion date: February 2012

Study information

• Verified date: October 2012
• Source: Klinikum St. Georg gGmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Surgery

Intervention

Procedure:
• MED-SEP
intraoperative neurophysiological monitoring
• TRI-SEP
intraoperative neurophysiologic monitoring
• neuropsychological tests
neurological short- and longterm outcome

Locations

Country	Name	City	State
Germany	Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum St. Georg gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of episodes of cerebral ischemia during carotid surgery		intraoperative, 28 days, and 60 days after surgery	No