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
PHASE3
242 participants
INTERVENTIONAL
2010-02-28
2012-03-31
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
PREVENTION
SINGLE
Study Groups
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Capnography
Arm with capnographic monitoring
Capnography
Capnographic monitoring
Standard
Standard monitoring.
Standard monitoring
Standard monitoring
Interventions
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Capnography
Capnographic monitoring
Standard monitoring
Standard monitoring
Eligibility Criteria
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Inclusion Criteria
* Scheduled for colonoscopy with midazolam and propofol sedation
Exclusion Criteria
* ASA V
* Pregnancy
* Prexisting hypotension, bradycardia or hypoxemia
18 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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II. Medizinische Klinik der Technischen Universität München
Principal Investigators
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Stefan von Delius, MD
Role: PRINCIPAL_INVESTIGATOR
Technical University of Munich
Locations
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Technische Universität München
Munich, Bavaria, Germany
Knappschaftskrankenhaus der Ruhr-Universität Bochum
Bochum, , Germany
Deutsche Klinik für Diagnostik
Wiesbaden, , Germany
Countries
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References
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Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
Klare P, Reiter J, Meining A, Wagenpfeil S, Kronshage T, Geist C, Heringlake S, Schlag C, Bajbouj M, Schneider G, Schmid RM, Wehrmann T, von Delius S, Riphaus A. Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study). Endoscopy. 2016 Jan;48(1):42-50. doi: 10.1055/s-0034-1393117. Epub 2015 Sep 28.
Related Links
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II. Medizinische Klinik der Technischen Universität München
Other Identifiers
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2680/10
Identifier Type: -
Identifier Source: org_study_id