We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Technical University of Munich.
Recruitment status was:  Not yet recruiting
First Posted : December 8, 2006
Last Update Posted : December 8, 2006
Sponsor:
Information provided by:
Technical University of Munich

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Propofol Drug: Prilocaine Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EEG and Auditory Evoked Potentials During Local Anesthesia
Study Start Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location 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
Layout table for location information
Germany
Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technical University of Munich
Investigators
Layout table for investigator information
Study Chair: Eberhard Kochs, MD Klinikum rechts der Isar der Technischen Universität München
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00408941    
Other Study ID Numbers: 1505/06
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: December 8, 2006
Last Verified: December 2006
Keywords provided by Technical University of Munich:
EEG
AEP
Artefacts
Propofol
Local Anaesthesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Propofol
Prilocaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents