CClinicalTrials.gg
Status unknownNCT00434382BEOUpdated Jul 30, 2010

Neuronal Mechanisms of Sensory Processing During General Anesthesia

An interventional study of Sevoflurane and Isoflurane in General Anesthesia, sponsored by Ludwig-Maximilians - University of Munich. Status unknown at 4 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-07-30.

Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
768
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • General Anesthesia

Keywords

  • auditory evoked potentials
  • sensory processing
  • monitoring
  • general anesthesia
03

In context

Lead sponsor

Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
768 participants

Interventions

  • DrugSevoflurane
  • DrugIsoflurane
  • DrugDesflurane
  • DrugPropofol
  • DrugFentanyl
  • DrugSufentanil
  • DrugAlfentanil
  • DrugRemifentanil
  • DeviceMidlatency auditory evoked potentials
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What researchers measure

Primary outcomes

  1. Intraoperative signs of inadequate anesthesia

  2. Postoperative recall of events

  3. MLAEP parameters

07

Study locations

4 sites
  • Krankenhaus Friedrichshafen
    Friedrichshafen, 88048, Germany
  • Klinik für Anaesthesia am Universitaetsklinikum Heidelber
    Heidelberg, 69120, Germany
  • Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck
    Lubeck, 23538, Germany
  • Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen
    Munich, 80336, Germany
08

References and documents

Publications

  • Scheller BC, Daunderer M, Pipa G. General anesthesia increases temporal precision and decreases power of the brainstem auditory-evoked response-related segments of the electroencephalogram. Anesthesiology. 2009 Aug;111(2):340-55. doi: 10.1097/ALN.0b013e3181acf7c0. PubMed 19602953 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00434382
Lead sponsor
Ludwig-Maximilians - University of Munich
Collaborators
CareFusion, German Federal Ministry of Education and Research
First posted
Feb 13, 2007
Start date
Oct 2002
Completion
Dec 2003
Last update
Jul 30, 2010

Study contacts

Michael AM Daunderer, M.D.,Ph.D.
principal investigator · Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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