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
  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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
EEG
AEP
Artefacts
Propofol
Local Anaesthesia

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

ClinicalTrials.gov processed this record on July 24, 2014