General AnesthesiaBEONCT00434382
Neuronal Mechanisms of Sensory Processing During General Anesthesia
A study testing Sevoflurane, Isoflurane and Desflurane in people with General Anesthesia, run by Ludwig-Maximilians - University of Munich at 4 sites in Germany.
Trial summary
The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Sevoflurane, Isoflurane and Desflurane
- Type of treatment
- Medical device
- How many people
- 768 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2002to Dec 2003
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Scheduled for elective urological, gynaecological or general surgery
- ASA status I or II
- Age 18 to 65
Who cannot join
- ASA status above II
- Operative procedures involving the neurocranium, neck or require other neurophysiologic monitoring
- Inability to communicate freely in the german language
- Major hearing deficit
- Regular centrally acting medication including drug abuse within 3 months prior to the investigation
- Participant of an other clinical investigation
- Lacking or withdrawal of written informed consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Krankenhaus Friedrichshafen
Friedrichshafen, 88048
Klinik für Anaesthesia am Universitaetsklinikum Heidelber
Heidelberg, 69120
Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck
Lübeck, 23538
Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen
Munich, 80336
About this study
Official title: Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose
The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
Read the detailed description
Up to now there is no fully functional and precise technique for accurate assessment for monitoring the degree of unconsciousness during general anaesthesia. Previous studies and results obtained during the project regarding the effect of anaesthetics on single neurons and small neuronal networks indicate that it would be most promising to use a method directly correlating to the integrity of the relevant functional systems. As one goal of the project it was formulated to develop and test a new system for recording and analysis of mid latency auditory evoked potentials (MLAEP), suitable to be used in the clinical surrounding of an operation theatre. Step by step an investigational system was developed, that after obtaining legal approvement was functional in a broad spectrum of cases. In a multicenter study the including 4 clinical centres and 426 patients the reliability of the system was proved. Even under the hard conditions of the OR the apparatus was able to record the signals with sufficient reliability and precision. A clear correlation of MLAEP parameters with clinically defined states of consciousness could be identified. Differences in the effect of the used combinations of general anaesthetics and opioids were identified. An algorithm for automatic analysis of the signals was developed, to allow users with limited knowledge of interpretation of MLAEP signals to use them for monitoring anaesthesia.
- Conditions
- General Anesthesia
- Being tested
- Sevoflurane, Isoflurane, Desflurane, Propofol, Fentanyl
- Keywords
- auditory evoked potentials, sensory processing, monitoring, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
IsofluraneDrug
DesfluraneDrug
PropofolDrug
FentanylDrug
SufentanilDrug
AlfentanilDrug
RemifentanilDrug
Midlatency auditory evoked potentialsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative signs of inadequate anesthesia
Postoperative recall of events
MLAEP parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startOct 2002
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 768 participants
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- C. R. Bard, German Federal Ministry of Education and Research
- Investigators
- Michael AM Daunderer, M.D.,Ph.D., Principal investigator, Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434382
- Sponsor's protocol ID
- BMBF 0311537
- Acronym
- BEO
- Status last verified
- Feb 2007
- First submitted
- 12 Feb 2007
- Last updated
- 30 Jul 2010
- Results posted
- No
Publications
Scheller BC, Daunderer M, Pipa G. General anesthesia increases temporal precision and decreases power of the brainstem auditory-evoked response-related segments of the electroencephalogram. Anesthesiology. 2009 Aug;111(2):340-55. doi: 10.1097/ALN.0b013e3181acf7c0.
PubMed 19602953
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose
- ClinicalTrials.gov ID
- NCT00434382
- Acronym / sponsor ID
- BEO / BMBF 0311537
- Conditions
- General Anesthesia
- Keywords
- auditory evoked potentials, sensory processing, monitoring, general anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 768 participants
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- C. R. Bard, German Federal Ministry of Education and Research
- Study start
- Oct 2002
- Study completion
- Dec 2003
- First posted
- 13 Feb 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.
The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.
Detailed description
Up to now there is no fully functional and precise technique for accurate assessment for monitoring the degree of unconsciousness during general anaesthesia. Previous studies and results obtained during the project regarding the effect of anaesthetics on single neurons and small neuronal networks indicate that it would be most promising to use a method directly correlating to the integrity of the relevant functional systems. As one goal of the project it was formulated to develop and test a new system for recording and analysis of mid latency auditory evoked potentials (MLAEP), suitable to be used in the clinical surrounding of an operation theatre. Step by step an investigational system was developed, that after obtaining legal approvement was functional in a broad spectrum of cases. In a multicenter study the including 4 clinical centres and 426 patients the reliability of the system was proved. Even under the hard conditions of the OR the apparatus was able to record the signals with sufficient reliability and precision. A clear correlation of MLAEP parameters with clinically defined states of consciousness could be identified. Differences in the effect of the used combinations of general anaesthetics and opioids were identified. An algorithm for automatic analysis of the signals was developed, to allow users with limited knowledge of interpretation of MLAEP signals to use them for monitoring anaesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients
- Scheduled for elective urological, gynaecological or general surgery
- ASA status I or II
- Age 18 to 65
Key exclusion criteria (7 listed)
- ASA status above II
- Operative procedures involving the neurocranium, neck or require other neurophysiologic monitoring
- Inability to communicate freely in the german language
- Major hearing deficit
- Regular centrally acting medication including drug abuse within 3 months prior to the investigation
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 |
|---|---|---|
| Sevoflurane | Drug | – |
| Isoflurane | Drug | – |
| Desflurane | Drug | – |
| Propofol | Drug | – |
| Fentanyl | Drug | – |
| Sufentanil | Drug | – |
| Alfentanil | Drug | – |
| Remifentanil | Drug | – |
| Midlatency auditory evoked potentials | Device | – |
Primary outcome
Intraoperative signs of inadequate anesthesia
Postoperative recall of events
MLAEP parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2010.
- Derived from this study: PubMed 19602953Scheller BC, Daunderer M, Pipa G. General anesthesia increases temporal precision and decreases power of the brainstem auditory-evoked response-related segments of the electroencephalogram. Anesthesiology. 2009 Aug;111(2):340-55. doi: 10.1097/ALN.0b013e3181acf7c0.
- homepage of the institute for medical psychology of the Ludwigs-Maximilians-University MunichLink provided by the sponsor.
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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.
Michael AM Daunderer, M.D.,Ph.D. principal investigator
Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Isoflurane and Desflurane in people with General Anesthesia, run by Ludwig-Maximilians - University of Munich at 4 sites 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 4 inclusion and 7 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 30 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
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?
Intraoperative signs of inadequate anesthesia. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00434382, which also lists 1 linked publication.
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 30 Jul 2010.