EEG and Auditory Evoked Potentials During Local Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2006-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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EEG AEP Artefacts Propofol Local Anaesthesia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Propofol

Intervention Type DRUG

Prilocaine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Eberhard Kochs, MD

Role: STUDY_CHAIR

Klinikum rechts der Isar der Technischen Universität München

Locations

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Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Central Contacts

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Gerhard Schneider, MD

Role: CONTACT

Phone: +49 89 4140 4291

Email: [email protected]

Sabine Paprotny, MD