NCT01072474CompletedPhase 3
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for ERCP
Technical University of Munich6 sites in 1 country242 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 242
- Locations
- 6
- Primary Endpoint
- Hypoxemia
Study Overview
Brief Summary
In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.
Detailed Description
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled for colonoscopy with midazolam and propofol sedation
Exclusion Criteria
- •No informed consent
- •Pregnancy
- •Prexisting hypotension, bradycardia or hypoxemia
Outcomes
Primary Outcomes
Hypoxemia
Time Frame: From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h
Secondary Outcomes
- Further complications(From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h)
Investigators
Study Sites (6)
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