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EEG and Auditory Evoked Potentials During Local Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Technische Universität München.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00408941
First received: December 7, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 7, 2006
December 7, 2006
December 2006
Not Provided
differences of AEP during sedation with and without local anaesthesia
Same as current
No Changes Posted
  • fraction of high frequency artefacts
  • time to LOC
  • differences AEP awake with and without local anaesthesia
Same as current
Not Provided
Not Provided
 
EEG and Auditory Evoked Potentials During Local Anesthesia
EEG and Auditory Evoked Potentials During Local Anesthesia

The aim of the present study was to investigate the sensitivity of AEP (auditory evoked potentials) to muscular artefacts using sedation and local anesthesia.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
  • Drug: Propofol
  • Drug: Prilocaine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
15
December 2006
Not Provided

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

  • drugs that effect the central nervous system
  • neurological or psychiatric deceases
  • contraindications against use of propofol or local anesthesia
Male
18 Years to 35 Years
Yes
Contact: Gerhard Schneider, MD +49 89 4140 4291 gerhard.schneider@lrz.tum.de
Contact: Sabine Paprotny, MD +49 89 4140 4291 s_paprotny@web.de
Germany
 
NCT00408941
1505/06
Not Provided
Not Provided
Technische Universität München
Not Provided
Study Chair: Eberhard Kochs, MD Klinikum rechts der Isar der Technischen Universität München
Technische Universität München
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP