Neuronal Mechanisms of Sensory Processing During General Anesthesia (BEO)

July 29, 2010 updated by: Ludwig-Maximilians - University of Munich

Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose

The ability of Mid Latency Auditory Evoked Potentials for a routine monitoring of sensory suppression should be evaluated during a wide spectrum of clinically common forms general anesthesia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Up to now there is no fully functional and precise technique for accurate assessment for monitoring the degree of unconsciousness during general anaesthesia. Previous studies and results obtained during the project regarding the effect of anaesthetics on single neurons and small neuronal networks indicate that it would be most promising to use a method directly correlating to the integrity of the relevant functional systems. As one goal of the project it was formulated to develop and test a new system for recording and analysis of mid latency auditory evoked potentials (MLAEP), suitable to be used in the clinical surrounding of an operation theatre. Step by step an investigational system was developed, that after obtaining legal approvement was functional in a broad spectrum of cases. In a multicenter study the including 4 clinical centres and 426 patients the reliability of the system was proved. Even under the hard conditions of the OR the apparatus was able to record the signals with sufficient reliability and precision. A clear correlation of MLAEP parameters with clinically defined states of consciousness could be identified. Differences in the effect of the used combinations of general anaesthetics and opioids were identified. An algorithm for automatic analysis of the signals was developed, to allow users with limited knowledge of interpretation of MLAEP signals to use them for monitoring anaesthesia.

Study Type

Interventional

Enrollment

768

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Friedrichshafen, Germany, 88048
        • Krankenhaus Friedrichshafen
      • Heidelberg, Germany, 69120
        • Klinik für Anaesthesia am Universitaetsklinikum Heidelber
      • Lubeck, Germany, 23538
        • Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck
      • Munich, Germany, 80336
        • Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients
  • Scheduled for elective urological, gynaecological or general surgery
  • ASA status I or II
  • Age 18 to 65

Exclusion Criteria:

  • ASA status above II
  • Operative procedures involving the neurocranium, neck or require other neurophysiologic monitoring
  • Inability to communicate freely in the german language
  • Major hearing deficit
  • Regular centrally acting medication including drug abuse within 3 months prior to the investigation
  • Participant of an other clinical investigation
  • Lacking or withdrawal of written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Intraoperative signs of inadequate anesthesia
Postoperative recall of events
MLAEP parameters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

German Federal Ministry of Education and Research
CareFusion

Investigators

  • Principal Investigator: Michael AM Daunderer, M.D.,Ph.D., Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

July 30, 2010

Last Update Submitted That Met QC Criteria

July 29, 2010

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMBF 0311537

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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