Trigeminus-evoked Somatosensory Potentials in Patients Un... | NCT00484796

Studies
Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery

NCT00484796

Sponsor

Klinikum St. Georg gGmbH

Status

Completed

Last Update Posted

Oct 29, 2012Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Carotid Surgery

Interventions

MED-SEP
TRI-SEP
neuropsychological tests

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISRCTN47041942

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Jun 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Jun 8, 2007

First Submission Date that Met QC Criteria

Jun 8, 2007

First Posted Date

Jun 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2012

Last Update Posted Date

Oct 29, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients undergoing carotid surgery	Procedure: MED-SEP Procedure: TRI-SEP Procedure: neuropsychological tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MED-SEP	Procedure	intraoperative neurophysiological monitoring	1
TRI-SEP

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing carotid surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin R Sablotzki, MD	Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy		Leipzig	Saxony	04129	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002545	Brain Ischemia
D003072	Cognition Disorders

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009483	Neuropsychological Tests

Ancestor Terms

ID	Term
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided