Condition category
Surgery
Date applied
31/08/2006
Date assigned
21/09/2006
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Malcharek Michael

ORCID ID

Contact details

Klinikum St. Georg gGmbH
Clinics of Anaesthesiology
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
Leipzig
04105
Germany
+49 (0)341 909 2570
michael.malcharek@sanktgeorg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00484796

Protocol/serial number

EK-BR-22/06-1

Study information

Scientific title

Acronym

TRI-SEP-Study

Study hypothesis

Trigemus-evoked Somatosensory Potentials (TRI-SEP) may be used as an alternative to Medianus-evoked Somatosensory Potentials (MED-SEP) for the detection of cerebral ischaemic events during elective carotid surgery.

Ethics approval

Approval by the Ethics Committee of the Saxonian Chamber of Physicians (Ref-Nr: EK-BR-22/0-1).

Study design

Prospective, open, clinical study.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Detection of cerebral ischaemic events during elective carotid surgery

Intervention

This study will compare the validity of both methods to detect cerebral ischaemic events, therefore in all patients Medianus- (MED-SEP) and Trigeminus- (TRI-SEP) evoked somatosensory potentials were taken during elective carotid surgery. The cognitive tests were taken in all patients preoperatively and in the early postoperative course to document the cognitive function and detect cognitive disorders.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Cerebral ischaemic events during elective carotid surgery

Secondary outcome measures

Results of cognitive tests

Overall trial start date

15/09/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Agreemant with study procedures and informed consent
3. Elective carotid surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Inability to take somatosensory potentials
2. Inability to respond to the cognitive tests

Recruitment start date

15/09/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Klinikum St. Georg gGmbH
Leipzig
04105
Germany

Sponsor information

Organisation

Klinikum St. Georg gGmbH (Germany)

Sponsor details

Clinic of Anaesthesia
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
Leipzig
04105
Germany
+49 (0)341 909 2570
kais@sanktgeorg.de

Sponsor type

Hospital/treatment centre

Website

http://www.sanktgeorg.de

Funders

Funder type

Hospital/treatment centre

Funder name

This study is funded by our institution: Clinics of Anesthesiology, Critical Care and Pain Therapy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20965778

Publication citations

  1. Results

    Malcharek MJ, Landgraf J, Hennig G, Sorge O, Aschermann J, Sablotzki A, Recordings of long-latency trigeminal somatosensory-evoked potentials in patients under general anaesthesia., Clin Neurophysiol, 2011, 122, 5, 1048-1054, doi: 10.1016/j.clinph.2010.08.017.

Additional files

Editorial Notes