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Neuronal Mechanisms of Sensory Processing During General Anesthesia (BEO)
This study is ongoing, but not recruiting participants.
First Received: February 12, 2007   No Changes Posted
Sponsors and Collaborators: Ludwig-Maximilians - University of Munich
Viasys Healthcare
German Federal Ministry of Education and Research
Information provided by: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT00434382
  Purpose

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.


Condition Intervention
General Anesthesia
Drug: Sevoflurane
Drug: Isoflurane
Drug: Desflurane
Drug: Propofol
Drug: Fentanyl
Drug: Sufentanil
Drug: Alfentanil
Drug: Remifentanil
Device: Midlatency auditory evoked potentials

Study Type: Interventional
Study Design: Supportive Care, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Intraoperative signs of inadequate anesthesia
  • Postoperative recall of events
  • MLAEP parameters

Estimated Enrollment: 768
Study Start Date: October 2002
Estimated Study Completion Date: December 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434382

Locations
Germany
Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen
Munich, Germany, 80336
Klinik für Anaesthesia am Universitaetsklinikum Heidelber
Heidelberg, Germany, 69120
Krankenhaus Friedrichshafen
Friedrichshafen, Germany, 88048
Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck
Lubeck, Germany, 23538
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Viasys Healthcare
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Michael AM Daunderer, M.D.,Ph.D. Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen
  More Information

Additional Information:
No publications provided

Study ID Numbers: BMBF 0311537
Study First Received: February 12, 2007
Last Updated: February 12, 2007
ClinicalTrials.gov Identifier: NCT00434382     History of Changes
Health Authority: Germany: Ethics Commission

Keywords provided by Ludwig-Maximilians - University of Munich:
auditory evoked potentials
sensory processing
monitoring
general anesthesia

Study placed in the following topic categories:
Anesthetics, Intravenous
Fentanyl
Remifentanil
Adjuvants, Immunologic
Anesthetics
Central Nervous System Depressants
Alfentanil
Narcotics
Sufentanil
Sevoflurane
Anesthetics, Inhalation
Desflurane
Anesthetics, General
Hypnotics and Sedatives
Isoflurane
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Propofol
Analgesics, Opioid

Additional relevant MeSH terms:
Anesthetics, Intravenous
Remifentanil
Hematologic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Alfentanil
Narcotics
Sufentanil
Pharmacologic Actions
Sevoflurane
Adjuvants, Anesthesia
Anesthetics, Inhalation
Desflurane
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Isoflurane
Platelet Aggregation Inhibitors
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 02, 2009