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Neuronal Mechanisms of Sensory Processing During General Anesthesia

NCT ID: NCT00434382

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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General Anesthesia

Keywords

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auditory evoked potentials sensory processing monitoring general anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Interventions

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Sevoflurane

Intervention Type DRUG

Isoflurane

Intervention Type DRUG

Desflurane

Intervention Type DRUG

Propofol

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Sufentanil

Intervention Type DRUG

Alfentanil

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Midlatency auditory evoked potentials

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CareFusion

INDUSTRY

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Principal Investigators

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Michael AM Daunderer, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen

Locations

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Krankenhaus Friedrichshafen

Friedrichshafen, , Germany

Site Status

Klinik für Anaesthesia am Universitaetsklinikum Heidelber

Heidelberg, , Germany

Site Status

Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck

Lübeck, , Germany

Site Status

Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen

Munich, , Germany

Site Status

Countries

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Germany

References

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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. doi: 10.1097/ALN.0b013e3181acf7c0.

Reference Type DERIVED
PMID: 19602953 (View on PubMed)

Related Links

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http://www.imp.med.uni-muenchen.de/index.html

homepage of the institute for medical psychology of the Ludwigs-Maximilians-University Munich

Other Identifiers

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BMBF 0311537

Identifier Type: -

Identifier Source: org_study_id