NCT00484796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

4.7 years

First QC Date

June 8, 2007

Last Update Submit

October 26, 2012

Conditions

Carotid Surgery

Keywords

Carotid SurgeryCerebral IschemiaCognitive DeficitsSomatosensory-evoked PotentialsNeuromonitoring

Outcome Measures

Primary Outcomes (1)

  • detection of episodes of cerebral ischemia during carotid surgery

    intraoperative, 28 days, and 60 days after surgery

Study Arms (1)

1

Patients undergoing carotid surgery

Procedure: MED-SEPProcedure: TRI-SEPProcedure: neuropsychological tests

Interventions

MED-SEPPROCEDURE

intraoperative neurophysiological monitoring

1
TRI-SEPPROCEDURE

intraoperative neurophysiologic monitoring

1
neuropsychological testsPROCEDURE

neurological short- and longterm outcome

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing carotid surgery

You may qualify if:

  • Age \>= 18 years
  • Agreement with study procedure
  • Elective carotid surgery

You may not qualify if:

  • Inability to take somatosensory potentials
  • Inability to respond to neuropsychological tests
  • Severe preoperative neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Leipzig, Saxony, 04129, Germany

Location

MeSH Terms

Conditions

Brain IschemiaCognition Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Armin R Sablotzki, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

October 1, 2006

Primary Completion

June 1, 2011

Study Completion

February 1, 2012

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

DE(1)