Phase 2 N=8 Randomized Single-blind Treatment

Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion

Brain Injury · Intracranial Pressure

Bottom Line

View on ClinicalTrials.gov: NCT00538616 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Apr 2013

Primary outcome: Primary: Lactate/Pyruvate (L/P)Ratio — 103.1; 33.8 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexmedetomidine (Drug); Propofol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Carmelo Graffagnino
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Lactate/Pyruvate (L/P)Ratio	103.1; 33.8	—

Summary

The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

Eligibility Criteria

Inclusion Criteria

primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
Must require (be on) mechanical ventilation
must require (have in place) intracranial pressure (ICP) monitoring
must require (be receiving) continuous IV sedation

Exclusion Criteria

Bleeding diathesis
Glasgow Coma Scale (GCS) < 5 with fixed pupils
Pregnant
elevated ICP that requires deep sedation
pulmonary instability
Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
status epilepticus
current neuromuscular blockade

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00538616). 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.