NCT00408941

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
Last Updated

December 8, 2006

Status Verified

December 1, 2006

First QC Date

December 7, 2006

Last Update Submit

December 7, 2006

Conditions

Healthy

Keywords

EEGAEPArtefactsPropofolLocal Anaesthesia

Outcome Measures

Primary Outcomes (1)

  • differences of AEP during sedation with and without local anaesthesia

Secondary Outcomes (3)

  • fraction of high frequency artefacts

  • time to LOC

  • differences AEP awake with and without local anaesthesia

Interventions

PropofolDRUG
PrilocaineDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status 1-2

You may not qualify if:

  • drugs that effect the central nervous system
  • neurological or psychiatric deceases
  • contraindications against use of propofol or local anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

PropofolPrilocaine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Eberhard Kochs, MD

    Klinikum rechts der Isar der Technischen Universität München

    STUDY CHAIR

Central Study Contacts

Gerhard Schneider, MD

CONTACT

+49 89 4140 4291gerhard.schneider@lrz.tum.de

Sabine Paprotny, MD

CONTACT

+49 89 4140 4291s_paprotny@web.de

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 8, 2006

Record last verified: 2006-12

Locations

DE(1)