HealthyPhase 4NCT00408941
EEG and Auditory Evoked Potentials During Local Anesthesia
A Phase 4 study testing Propofol and Prilocaine in people with Healthy, run by Technical University of Munich at 1 site in Germany.
Trial summary
The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propofol and Prilocaine
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2006to Dec 2006
- Phase
- Phase 4
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-2
Who cannot join
- drugs that effect the central nervous system
- neurological or psychiatric deceases
- contraindications against use of propofol or local anesthesia
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, 81675
About this study
The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.
Read the detailed description
Spontaneous or evoked electrical brain activity is increasingly used to monitor general anesthesia. During alertness, surgery and anesthesia the quality of AEP recordings may be reduced by artefacts. This poses the question to what extent AEP are sensitive for muscular artefacts. High frequency artefacts can have its seeds in muscles and in technical instruments in the operating room. Therefore, the study will take place under the terms of laboratory.
The present study was designed to measure the influence of muscular artefacts on AEP under propofol sedation with or without local anesthesia in the area of the electrodes.
If artefacts influence AEP, which are used to measure anesthesia, it is particularly interesting with regard to clinical application. AEP as a measure of "anesthetic depth" may not only reflect brain, but also muscular and high frequency activity. Therefore, while using muscle relaxants, the AEP of an awake patient may indicate deep anesthesia, because muscle signals are absent.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
PrilocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
differences of AEP during sedation with and without local anaesthesia
Secondary outcomes (3)
fraction of high frequency artefacts
time to LOC
differences AEP awake with and without local anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Eberhard Kochs, MD, Study chair, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408941
- Sponsor's protocol ID
- 1505/06
- Status last verified
- Dec 2006
- First submitted
- 7 Dec 2006
- Last updated
- 8 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG and Auditory Evoked Potentials During Local Anesthesia
- ClinicalTrials.gov ID
- NCT00408941
- Acronym / sponsor ID
- 1505/06
- Conditions
- Healthy
- Keywords
- EEG, AEP, Artefacts, Propofol, Local Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Dec 2006
- First posted
- 8 Dec 2006 (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.
The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.
Detailed description
Spontaneous or evoked electrical brain activity is increasingly used to monitor general anesthesia. During alertness, surgery and anesthesia the quality of AEP recordings may be reduced by artefacts. This poses the question to what extent AEP are sensitive for muscular artefacts. High frequency artefacts can have its seeds in muscles and in technical instruments in the operating room. Therefore, the study will take place under the terms of laboratory.
The present study was designed to measure the influence of muscular artefacts on AEP under propofol sedation with or without local anesthesia in the area of the electrodes.
If artefacts influence AEP, which are used to measure anesthesia, it is particularly interesting with regard to clinical application. AEP as a measure of "anesthetic depth" may not only reflect brain, but also muscular and high frequency activity. Therefore, while using muscle relaxants, the AEP of an awake patient may indicate deep anesthesia, because muscle signals are absent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status 1-2
Key exclusion criteria (3 listed)
- drugs that effect the central nervous system
- neurological or psychiatric deceases
- contraindications against use of propofol or local anesthesia
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 |
|---|---|---|
| Propofol | Drug | – |
| Prilocaine | Drug | – |
Primary outcome
differences of AEP during sedation with and without local anaesthesia
3 secondary outcomes
fraction of high frequency artefacts
time to LOC
differences AEP awake with and without local anaesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2006.
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
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.
Eberhard Kochs, MD study chair
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Prilocaine in people with Healthy, run by Technical University of Munich 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 1 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: status not confirmed, as of the sponsor's last update on 8 Dec 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Schneider, MD (+49 89 4140 4291, gerhard.schneider@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences of AEP during sedation with and without local anaesthesia. 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 8 Dec 2006.