NCT00434382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
768

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2002

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

July 30, 2010

Status Verified

February 1, 2007

First QC Date

February 12, 2007

Last Update Submit

July 29, 2010

Conditions

General Anesthesia

Keywords

auditory evoked potentialssensory processingmonitoringgeneral anesthesia

Outcome Measures

Primary Outcomes (3)

  • Intraoperative signs of inadequate anesthesia

  • Postoperative recall of events

  • MLAEP parameters

Interventions

SevofluraneDRUG
IsofluraneDRUG
DesfluraneDRUG
PropofolDRUG
FentanylDRUG
SufentanilDRUG
AlfentanilDRUG
RemifentanilDRUG
Midlatency auditory evoked potentialsDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients
  • Scheduled for elective urological, gynaecological or general surgery
  • ASA status I or II
  • Age 18 to 65

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Krankenhaus Friedrichshafen

Friedrichshafen, 88048, Germany

Location

Klinik für Anaesthesia am Universitaetsklinikum Heidelber

Heidelberg, 69120, Germany

Location

Klinik fuer Anaesthesiologie am Universitätsklinikum Schleswig Holstein, Campus Luebeck

Lübeck, 23538, Germany

Location

Klinik fuer Anaesthesiologie der Ludwigs-Maximilians-Universitaet Muenchen

Munich, 80336, Germany

Location

Related Publications (1)

  • 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.

    PMID: 19602953DERIVED

Related Links

MeSH Terms

Interventions

SevofluraneIsofluraneDesfluranePropofolFentanylSufentanilAlfentanilRemifentanil

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl EthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic Acids

Study Officials

  • Michael AM Daunderer, M.D.,Ph.D.

    Klinik fuer Anaesthesiologie, Ludwig-Maximilians-Universitaet Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 13, 2007

Study Start

October 1, 2002

Study Completion

December 1, 2003

Last Updated

July 30, 2010

Record last verified: 2007-02

Locations

DE(4)