Brain Injury, Intracranial Pressure
Conditions
Keywords
Brain Injury
Brief 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.
Detailed description
The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.
Interventions
DRUGDexmedetomidine
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
DRUGPropofol
in this crossover study, subjects will receive 6 hours of propofol and 6 hours of precedex (randomized crossover)
Sponsors
Hospira, now a wholly owned subsidiary of Pfizer
Carmelo Graffagnino
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactate/Pyruvate (L/P)Ratio | 1 hour | L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial. |
Countries
United States
Participant flow
Recruitment details
Subjects approached if they had indwelling Licox catheters and were given sedation.
Pre-assignment details
Study started at onset of shift with 1 hour washout between crossover. One subject taken off sedation prior to enrollment because they were no longer eligible
Participants by arm
| Arm | Count |
|---|---|
| Precedex-Propofol Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours. | 5 |
| Propofol- Precedex Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours. | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | Propofol- Precedex | Precedex-Propofol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 7 Participants |
| Age Continuous | 55 years STANDARD_DEVIATION 8.6 | 33 years STANDARD_DEVIATION 5.6 | 41.5 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 3 participants | 5 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 5 | 0 / 3 |
| serious Total, serious adverse events | 1 / 5 | 0 / 3 |
Outcome results
Primary
Lactate/Pyruvate (L/P)Ratio
L/P ratio was measured before during and after sedation assessment. The micromole value for each dialysate (lactate and pyruvate) was reported as well as the ratio (L/P). Elevated ratios (greater than 30) were attributed to metabolic distress (relative hypoxemia)during the course of the trial.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Precedex-Propofol | Lactate/Pyruvate (L/P)Ratio | 103.1 ratio | Standard Deviation 249.5 |
| Propofol- Precedex | Lactate/Pyruvate (L/P)Ratio | 33.8 ratio | Standard Deviation 10.7 |