Altered Mental Status
Conditions
Keywords
Sedation
Brief summary
The purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (CT) or magnetic resonance imaging (MRI) in those greater than or equal to 65 years of age (older adults) that are seen in the Emergency Department (ED).
Interventions
DRUGDexmedetomidine
Intranasal dexmedetomidine, 100mcg
DRUGLorazepam
0.5mg IV
DRUGHaloperidol
0.5mg IV
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years of age and older * Patients in need of sedation prior to either a computerized tomography (CT) or magnetic resonance imaging (MRI)
Exclusion criteria
* Patients who weigh \< 50 kg * Cardiac arrhythmias or QTc \>450 * Intravenous access not standard of care or unable to obtain * Patients with any allergies or contraindications to dexmedetomidine, haloperidol (i.e. patients diagnosed with Parkinson's) or lorazepam * Patients with low blood pressure, defined as a less than 100/60 mmHg * Patients with bradycardia (Heart rate \< 60 bpm) * Patients presenting with chief complaint of respiratory distress/failure * Intranasal administration contradictions: nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal damage, recent use of nasally administered vasoconstrictors such as cocaine, oxymetazoline, and phenylephrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | Within one hour of administration | The primary outcome is to determine if intranasal dexmedetomidine is as effective in producing moderate sedation on the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) as standard of care intravenous medications in older adults. The minimum value on the Modified Observer's Assessment of Alertness/Sedation Scale is 0 and the maximum value is 5. Lower scores mean a worse outcome. |
Contacts
Primary ContactJay M Brenner, MD
Backup ContactJaylan Hayes, PharmMD
Outcome results
None listed