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 (NCT) | NCT00484796 |
| Protocol serial number | EK-BR-22/06-1 |
| Sponsor | Klinikum St. Georg gGmbH (Germany) |
| Funder | This study is funded by our institution: Clinics of Anesthesiology, Critical Care and Pain Therapy |
- 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
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 |
|---|---|
| michael.malcharek@sanktgeorg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, open, clinical study. |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | TRI-SEP-Study |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
Cerebral ischaemic events during elective carotid surgery |
| Key secondary outcome measure(s) |
Results of cognitive tests |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Aged over 18 years 2. Agreemant with study procedures and informed consent 3. Elective carotid surgery |
| Key exclusion criteria | 1. Inability to take somatosensory potentials 2. Inability to respond to the cognitive tests |
| Date of first enrolment | 15/09/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum St. Georg gGmbH
Leipzig
04105
Germany
04105
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
