EEG and Auditory Evoked Potentials During Local Anesthesia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00408941|
Recruitment Status : Unknown
Verified December 2006 by Technische Universität München.
Recruitment status was: Not yet recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Propofol Drug: Prilocaine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||EEG and Auditory Evoked Potentials During Local Anesthesia|
|Study Start Date :||December 2006|
|Study Completion Date :||December 2006|
- differences of AEP during sedation with and without local anaesthesia
- fraction of high frequency artefacts
- time to LOC
- differences AEP awake with and without local anaesthesia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408941
|Contact: Gerhard Schneider, MD||+49 89 4140 email@example.com|
|Contact: Sabine Paprotny, MD||+49 89 4140 firstname.lastname@example.org|
|Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology|
|Munich, Bavaria, Germany, 81675|
|Study Chair:||Eberhard Kochs, MD||Klinikum rechts der Isar der Technischen Universität München|