Status:
COMPLETED
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Gastrointestinal Endoscopy
Sedation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) moni...
Eligibility Criteria
Inclusion
- Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation
Exclusion
- Missing informed consent
- ASA V
- Preexisting neurological deficit
- Known pregnancy
- Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00952458
Start Date
July 1 2009
End Date
May 1 2010
Last Update
August 24 2012
Active Locations (1)
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1
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany, 81675