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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20965778
Publication citations
-
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.