Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
NCT ID: NCT00952458
Last Updated: 2012-08-24
Study Results
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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COMPLETED
NA
144 participants
INTERVENTIONAL
2009-07-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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BIS monitoring
Dosing of sedatives with BIS monitoring
BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index
Standard monitoring
Dosing of sedatives without BIS monitoring
No interventions assigned to this group
Interventions
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BIS monitoring
Neuromonitoring of depth of sedation with Bispectral Index
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* ASA V
* Preexisting neurological deficit
* Known pregnancy
* Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Technical University of Munich
OTHER
Responsible Party
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Klinikum rechts der Isar der Technischen Universität München
Principal Investigators
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Stefan von Delius, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum rechts der Isar der Technischen Universität München
Locations
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Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany
Countries
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References
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von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.
Other Identifiers
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2094/08
Identifier Type: -
Identifier Source: org_study_id