Comparison of TRIgemus-evoked SomatosEnsory Potentials and medianus-evoked somatosensory potentials in patients undergoing carotid surgery

ISRCTN ISRCTN47041942
DOI https://doi.org/10.1186/ISRCTN47041942
ClinicalTrials.gov number NCT00484796
Secondary identifying numbers EK-BR-22/06-1
Submission date
31/08/2006
Registration date
21/09/2006
Last edited
04/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Malcharek Michael
Scientific

Klinikum St. Georg gGmbH
Clinics of Anaesthesiology
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
Leipzig
04105
Germany

Phone +49 (0)341 909 2570
Email michael.malcharek@sanktgeorg.de

Study information

Study designProspective, open, clinical study.
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeScreening
Scientific title
Study acronymTRI-SEP-Study
Study objectivesTrigemus-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(s)Approval by the Ethics Committee of the Saxonian Chamber of Physicians (Ref-Nr: EK-BR-22/0-1).
Health condition(s) or problem(s) studiedDetection of cerebral ischaemic events during elective carotid surgery
InterventionThis 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 typeProcedure/Surgery
Primary outcome measureCerebral ischaemic events during elective carotid surgery
Secondary outcome measuresResults of cognitive tests
Overall study start date15/09/2006
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Aged over 18 years
2. Agreemant with study procedures and informed consent
3. Elective carotid surgery
Key exclusion criteria1. Inability to take somatosensory potentials
2. Inability to respond to the cognitive tests
Date of first enrolment15/09/2006
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinikum St. Georg gGmbH
Leipzig
04105
Germany

Sponsor information

Klinikum St. Georg gGmbH (Germany)
Hospital/treatment centre

Clinic of Anaesthesia
Critical Care and Pain Therapy
Delitzscher Str. 141
Haus 20
Leipzig
04105
Germany

Phone +49 (0)341 909 2570
Email kais@sanktgeorg.de
Website http://www.sanktgeorg.de
ROR logo "ROR" https://ror.org/02y8hn179

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2011 Yes No