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EEG and Auditory Evoked Potentials During Local Anesthesia

EEG and Auditory Evoked Potentials During Local Anesthesia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00408941
Enrollment
15
Registered
2006-12-08
Start date
2006-12-31
Completion date
2006-12-31
Last updated
2006-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

EEG, AEP, Artefacts, Propofol, Local Anaesthesia

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.

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.

Interventions

DRUGPropofol

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
differences of AEP during sedation with and without local anaesthesia

Secondary

MeasureTime frame
fraction of high frequency artefacts
time to LOC
differences AEP awake with and without local anaesthesia

Countries

Germany

Contacts

Primary ContactGerhard Schneider, MD
gerhard.schneider@lrz.tum.de+49 89 4140 4291
Backup ContactSabine Paprotny, MD
s_paprotny@web.de+49 89 4140 4291

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026