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
Information provided by:
Technische Universität München Identifier:
First received: December 7, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

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

Condition Intervention Phase
Drug: Propofol
Drug: Prilocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: EEG and Auditory Evoked Potentials During Local Anesthesia

Resource links provided by NLM:

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • differences of AEP during sedation with and without local anaesthesia

Secondary Outcome Measures:
  • fraction of high frequency artefacts
  • time to LOC
  • differences AEP awake with and without local anaesthesia

Estimated Enrollment: 15
Study Start Date: December 2006
Estimated Study Completion Date: December 2006
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.


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00408941

Contact: Gerhard Schneider, MD +49 89 4140 4291
Contact: Sabine Paprotny, MD +49 89 4140 4291

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Study Chair: Eberhard Kochs, MD Klinikum rechts der Isar der Technischen Universität München
  More Information

No publications provided Identifier: NCT00408941     History of Changes
Other Study ID Numbers: 1505/06
Study First Received: December 7, 2006
Last Updated: December 7, 2006
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
Local Anaesthesia

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on October 09, 2015