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Propofol vs. Propofol w/ Alfentanil:
Data Sheet, Data Collection Tips, Study Flow, FAQs
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Overview:
A study designed to determine the
efficacy and safety of propofol vs. propofol w/ alfentanil in deep
procedural sedations |
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Study Endpoints:
1. Respiratory depression as assessed by ETCO2 2. Mental status as
assessed by BIS, OAAS, and patient report. |
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Eligible Patients:
Adult (≥18 y.o.) patients undergoing a procedural sedation for any
reason. |
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Study Design:
Prospective, randomized clinical trial.
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Anticipated
Benefits: BIS and ETCO2 monitoring mandated by the study may improve
safety of procedure.
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Potential Risks:
The usual risks associated with procedural sedation.
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Research Associate’s
Role: The RA is responsible for identifying, enrolling, and
collecting data from eligible patients for this study. The RA is in
charge of setting up and putting away the BIS and End-Tidal CO2
monitors used to obtain data during the procedure. After the study, the
RA conducts interviews of the physician and the patient.
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Physician’s Role:
The RA will ask you to notify them of any conscious sedations being
performed so that they may enter the patient into the study. You will
be asked to perform the sedation using either propofol or propofol w/
alfentanil. Once the procedure is over, you will be asked to complete a
short questionnaire about the success of the procedure and the time it
took for the patient to return to baseline mental status.
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Location of Study
Packets: Team Center B
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