EEG and Auditory Evoked Potentials During Local Anesthesia
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 7, 2006 | ||||||||
| Last Updated Date | December 7, 2006 | ||||||||
| Start Date ICMJE | December 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
differences of AEP during sedation with and without local anaesthesia | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | EEG and Auditory Evoked Potentials During Local Anesthesia | ||||||||
| Official Title ICMJE | EEG and Auditory Evoked Potentials During Local Anesthesia | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Enrollment ICMJE | 15 | ||||||||
| Completion Date | December 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 35 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00408941 | ||||||||
| Other Study ID Numbers ICMJE | 1505/06 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Technische Universität München | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Technische Universität München | ||||||||
| Verification Date | December 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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