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

Phase 3

Not yet recruiting

• Conditions: Altered Mental Status
• Interventions: Drug: Lorazepam; Drug: Haloperidol; Drug: Dexmedetomidine

• Registration Number: NCT06370442
• Lead Sponsor: State University of New York - Upstate Medical University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-17
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-22
• Study Start: 2024-06-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lorazepam	Lorazepam	-
Haloperidol	Haloperidol	-
IN Dex	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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.