Combining Observational and Physiologic Sedation Assessment Tools



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2006
End Date:September 2007

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When a physiologic tool to measure the patient's hypnotic state is added to current practice
tools is there a decrease in the amount of drug the patient receives.

The purposes of this study were to examine the effect of combining a physiologic measure of
consciousness (BIS) with observational assessment of sedation (Ramsay) on infused sedation
drug volumes, undersedation events, and the recovery time to arouse from sedation, in a
group of neurocritically ill patients. During a 12-hour data collection period, patients
received sedation assessment and management with either the current standard of care
(sedation assessment with the Ramsay scale), or the standard of care plus the addition of
physiologic data from BIS monitoring. Planned research questions explored how BIS monitoring
impacts short-term sedation-related outcomes.

Research Questions

- Is there less sedation drug use for patients when nurses monitor sedation with BIS
augmentation of Ramsay than when nurses monitor patients with Ramsay alone?

- Is sedation assessment augmented by BIS use associated with a decreased time to wake-up
(recovery time) when nurses are instructed to interrupt sedation and obtain a
neurologic examination, compared to use of Ramsay alone?

- Are there differences in the number of events associated with undersedation (e.g.,
self-extubation) for patients assigned to BIS augmentation compared to patients
assigned to Ramsay alone?

Inclusion Criteria:

- Adult

- admitted with a neurological or neurosurgical diagnosis

- intubated and on mechanical ventilatory support

- receiving continuous sedation with propofol

- Glasgow Coma Score <12

Exclusion Criteria:

- bifrontal brain injury

- status epilepticus

- barbiturate coma therapy

- continuous benzodiazepine administration
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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