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Neuronal Mechanisms of Sensory Processing During General Anesthesia

Neuronale Mechanismen Der Sensorischen Reizverarbeitung in Der Narkose

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00434382
Acronym
BEO
Enrollment
768
Registered
2007-02-13
Start date
2002-10-31
Completion date
2003-12-31
Last updated
2010-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

auditory evoked potentials, sensory processing, monitoring, general anesthesia

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.

Interventions

DRUGSevoflurane
DRUGIsoflurane
DRUGDesflurane
DRUGPropofol
DRUGFentanyl
DRUGSufentanil
DRUGAlfentanil
DRUGRemifentanil
DEVICEMidlatency auditory evoked potentials

Sponsors

C. R. Bard
CollaboratorINDUSTRY
German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Ludwig-Maximilians - University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Intraoperative signs of inadequate anesthesia
Postoperative recall of events
MLAEP parameters

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026