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Utility of
BiSpectral Monitoring of Procedural Sedation:
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Overview:
This study seeks to use an additional monitor (BIS) along with
normal monitors for a procedural sedation. This monitor is used to
predict how well sedated a person is and whether or not they will
remember the procedure.
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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:
Patients receiving conscious sedation for a fracture or dislocation
reduction. |
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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. A BIS
lead and an ETCO2
nosepiece will be placed on the patient to collect data during the
procedure. 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, to the left of the attending physician's computer.
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