EEG and Auditory Evoked Potentials During Local Anesthesia

Healthy Clinical Trial

Official title:

EEG and Auditory Evoked Potentials During Local Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00408941
• Other study ID #: 1505/06
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 7, 2006
• Last updated: December 7, 2006
• Start date: December 2006
• Est. completion date: December 2006

Study information

• Verified date: December 2006
• Source: Technische Universität München
• Contact: Gerhard Schneider, MD
• Phone: +49 89 4140 4291
• Email: gerhard.schneider[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Propofol

• Prilocaine

Locations

Country	Name	City	State
Germany	Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences of AEP during sedation with and without local anaesthesia
Secondary	fraction of high frequency artefacts
Secondary	time to LOC
Secondary	differences AEP awake with and without local anaesthesia