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Neuronal Mechanisms of Sensory Processing During General Anesthesia (BEO)
This study is ongoing, but not recruiting participants.
Study NCT00434382   Information provided by Ludwig-Maximilians - University of Munich
First Received: February 12, 2007   No Changes Posted

February 12, 2007
February 12, 2007
October 2002
 
  • Intraoperative signs of inadequate anesthesia
  • Postoperative recall of events
  • MLAEP parameters
Same as current
No Changes Posted
 
 
 
Neuronal Mechanisms of Sensory Processing During General Anesthesia
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.

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.

 
Interventional
Supportive Care, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
General Anesthesia
  • Drug: Sevoflurane
  • Drug: Isoflurane
  • Drug: Desflurane
  • Drug: Propofol
  • Drug: Fentanyl
  • Drug: Sufentanil
  • Drug: Alfentanil
  • Drug: Remifentanil
  • Device: Midlatency auditory evoked potentials
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
768
December 2003
 

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00434382
 
BMBF 0311537
Ludwig-Maximilians - University of Munich
  • Viasys Healthcare
  • German Federal Ministry of Education and Research
Principal Investigator: Michael AM Daunderer, M.D.,Ph.D. Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen
Ludwig-Maximilians - University of Munich
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP