Carotid SurgeryTRISEPNCT00484796
Trigeminus-evoked Somatosensory Potentials in Patients Undergoing Carotid Surgery
An observational study of Carotid Surgery, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Surgery
- What is being tested?
- MED-SEP, TRI-SEP and neuropsychological tests
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing carotid surgery
Who may be able to join
- Age >= 18 years
- Agreement with study procedure
- Elective carotid surgery
Who cannot join
- Inability to take somatosensory potentials
- Inability to respond to neuropsychological tests
- Severe preoperative neurological deficit
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
Leipzig, Saxony, 04129
About this study
Official title: Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery
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.
Read the 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.
- Conditions
- Carotid Surgery
- Being tested
- MED-SEP, TRI-SEP, neuropsychological tests
- Keywords
- Carotid Surgery, Cerebral Ischemia, Cognitive Deficits, Somatosensory-evoked Potentials, Neuromonitoring
- Medical subject headings
- Brain Ischemia, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-SEPProcedure or surgery
intraoperative neurophysiological monitoring
TRI-SEPProcedure or surgery
intraoperative neurophysiologic monitoring
neuropsychological testsProcedure or surgery
neurological short- and longterm outcome
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients undergoing carotid surgery Receives: Procedure: MED-SEP; Procedure: TRI-SEP; Procedure: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of episodes of cerebral ischemia during carotid surgery
Measured: intraoperative, 28 days, and 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, Principal investigator, Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484796
- Sponsor's protocol ID
- ISRCTN47041942
- Other IDs
- ISRCTN47041942
- Acronym
- TRISEP
- Status last verified
- Oct 2012
- First submitted
- 8 Jun 2007
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Trigeminus-evoked Somatosensory Potentials (TRI-SEP) and Medianus-evoked Somatosensory Potentials (MED-SEP) in Patients Undergoing Carotid Surgery
- ClinicalTrials.gov ID
- NCT00484796
- Acronym / sponsor ID
- TRISEP / ISRCTN47041942
- Conditions
- Carotid Surgery
- Keywords
- Carotid Surgery, Cerebral Ischemia, Cognitive Deficits, Somatosensory-evoked Potentials, Neuromonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: MED-SEP, Procedure: TRI-SEP, Procedure: neuropsychological testsPatients undergoing carotid surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid surgery
Key inclusion criteria (3 listed)
- Age >= 18 years
- Agreement with study procedure
- Elective carotid surgery
Key exclusion criteria (3 listed)
- Inability to take somatosensory potentials
- Inability to respond to neuropsychological tests
- Severe preoperative neurological deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MED-SEPintraoperative neurophysiological monitoring | Procedure or surgery | 1 |
| TRI-SEPintraoperative neurophysiologic monitoring | Procedure or surgery | 1 |
| neuropsychological testsneurological short- and longterm outcome | Procedure or surgery | 1 |
Primary outcome
detection of episodes of cerebral ischemia during carotid surgery
Time frame: intraoperative, 28 days, and 60 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin R Sablotzki, MD principal investigator
Klinikum St. Georg, Clinics of Anesthesiology, Critical Care and Pain Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Surgery, run by Klinikum St. Georg gGmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of episodes of cerebral ischemia during carotid surgery (time frame: intraoperative, 28 days, and 60 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.