Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult

State University of New York - Upstate Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Altered Mental Status

Treatments: Drug: Lorazepam; Drug: Haloperidol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06370442

2137695

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Lorazepam

Active Comparator group

Treatment:

Drug: Lorazepam

Haloperidol

Active Comparator group

Treatment:

Drug: Haloperidol

IN Dex

Experimental group

Treatment:

Drug: Dexmedetomidine