Phase 3
N=84
Cerebral Perfusion Pressure Using Precedex and Other Sedatives
Endotracheal Intubation · Continuous IV Sedation · ICP Monitoring
Bottom Line
View on ClinicalTrials.gov: NCT01169467 ↗Enrolled (actual)
84
Serious AEs
1.2%
Results posted
Nov 2015
Primary outcome: Primary: Variability of Intracranial Pressure (ICP) — 5.66; 5.61 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard-of-Care plus Dexmedetomidine (Drug); Standard-of-Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variability of Intracranial Pressure (ICP) |
5.66; 5.61 | — |
| PRIMARY Change in Pressure Reactivity Index (PRx) |
.64; .66 | 0.395 |
| SECONDARY Amount of Sedative/Analgesic Used During Treatment in Patients With Secondary Brain Injury |
155.4; 213.1 | — |
| SECONDARY Cerebral Perfusion Pressure Changes in Patients With Secondary Brain Injury |
11.5; 12.3 | — |
| SECONDARY Mean Arterial Blood Pressure (MAP) Variability in Patients With Secondary Brain Injury |
12.30; 13.8 | — |
Summary
The purpose of this study is to examine the effects of using dexmedetomidine (Precedex) in addition to the current standard-of-care for sedation.
Eligibility Criteria
Inclusion Criteria
- Admitted to Duke University Neuro Critical Care Unit (NCCU)
- Adult (18 years of age or older)
- Expected Mechanical Ventilation for >48 hours with sedation
- Intraventricular catheter in situ
Exclusion Criteria
- Hypersensitivity to study drugs
- Prisoners
- Moribund state or death expected within 24 hours
- Surgery planned within 24 hours of subject enrollment
- Receiving study drug, Precedex, prior to entering study
Data sourced from ClinicalTrials.gov (NCT01169467). 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.