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EEG and Auditory Evoked Potentials During Local Anesthesia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Technische Universität München.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408941
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
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.
Information provided by:
Technische Universität München
  Purpose
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
Healthy Drug: Propofol Drug: Prilocaine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

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


Contacts
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

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

ClinicalTrials.gov Identifier: NCT00408941     History of Changes
Other Study ID Numbers: 1505/06
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: December 8, 2006
Last Verified: December 2006

Keywords provided by Technische Universität München:
EEG
AEP
Artefacts
Propofol
Local Anaesthesia

Additional relevant MeSH terms:
Anesthetics
Propofol
Prilocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents