N/A Completed N=300 Randomized Treatment

Combining Objective and Subjective Sedation Assessment Tools

Critical Illness

Source: ClinicalTrials.gov NCT00734409 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcomePrimary: Mean Sedative Use — 13.35; 15.54 ml/hour

Summary

The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Sedative Use	13.35; 15.54	—
SECONDARY Unplanned Self-device Removal Events	0; 1	—
SECONDARY Mean Days on Mechanical Ventilation	7.43; 6.85	—

Eligibility Criteria

Inclusion Criteria

patient in the ICU
continuous IV sedation with propofol midazolam or dexmedetomidine
age > 18
expected to require mechanical ventilation for >=48 hours

Exclusion Criteria

prisoners
no available space on forehead
continuous electroencephalography(EEG) monitoring
bifrontal brain injury
barbiturate coma therapy
known hypersensitivity to study medications
high risk for ethanol (ETOH) withdrawal
resuscitation from cardiac arrest without recovery of mental status
moribund clinical state (death expected within 48 hours)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00734409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.