Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434382
Status:
UNKNOWN
Last Update Posted:
2010-07-30
First Post:
2007-02-12
Brief Title:
Neuronal Mechanisms of Sensory Processing During General Anesthesia
Sponsor:
Ludwig-Maximilians - University of Munich
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEO
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None