NCT01072487CompletedPhase 3
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Colonoscopy
Technical University of Munich6 sites in 1 country760 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 760
- Locations
- 6
- Primary Endpoint
- Hypoxemia
Study Overview
Brief Summary
In the study the value of capnography for avoiding complications during sedation for colonoscopy 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
- Yes
Inclusion Criteria
- •Scheduled for colonoscopy with midazolam and propofol sedation
Exclusion Criteria
- •No informed consent
- •ASA IV or V
- •Pregnancy
- •Prexisting hypotension, bradycardia or hypoxemia
Outcomes
Primary Outcomes
Hypoxemia
Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Secondary Outcomes
- Further complications(From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h)
Investigators
Study Sites (6)
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