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| Sponsor: | Ludwig-Maximilians - University of Munich |
|---|---|
| Collaborators: |
CareFusion 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Supportive Care |
| Official Title: | Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose |
| Estimated Enrollment: | 768 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | December 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Krankenhaus Friedrichshafen | |
| Friedrichshafen, Germany, 88048 | |
| Klinik für Anaesthesia am Universitaetsklinikum Heidelber | |
| Heidelberg, Germany, 69120 | |
| Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck | |
| Lubeck, Germany, 23538 | |
| Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen | |
| Munich, Germany, 80336 | |
| Principal Investigator: | Michael AM Daunderer, M.D.,Ph.D. | Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen |
More Information
| ClinicalTrials.gov Identifier: | NCT00434382 History of Changes |
| Other Study ID Numbers: | BMBF 0311537 |
| Study First Received: | February 12, 2007 |
| Last Updated: | July 29, 2010 |
| Health Authority: | Germany: Ethics Commission |
|
auditory evoked potentials sensory processing monitoring general anesthesia |
|
Alfentanil Fentanyl Sufentanil Propofol Remifentanil Anesthetics Isoflurane Desflurane Sevoflurane Narcotics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Adjuvants, Anesthesia Anesthetics, Inhalation Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents |