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

NCT06370442 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 2137695
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Altered Mental Status

Keywords

Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation

  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.

  Within one hour of administration

Study Arms (3)

Lorazepam

ACTIVE COMPARATOR

Drug: Lorazepam

Haloperidol

ACTIVE COMPARATOR

Drug: Haloperidol

IN Dex

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Intranasal dexmedetomidine, 100mcg

Also known as: Precedex

IN Dex

Lorazepam DRUG

0.5mg IV

Also known as: Ativan

Lorazepam

Haloperidol DRUG

0.5mg IV

Also known as: Haldol

Haloperidol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age and older
• Patients in need of sedation prior to either a computerized tomography (CT) or magnetic resonance imaging (MRI)

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Related Publications (11)

• Kennedy M, Koehl J, Gao J, Ciampa KA, Hayes BD, Camargo CA Jr. Use of antipsychotic and sedative medications in older patients in the emergency department. J Am Geriatr Soc. 2022 Mar;70(3):731-742. doi: 10.1111/jgs.17590. Epub 2021 Nov 25.

  PMID: 34820831 RESULT

• Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.

  PMID: 22144928 RESULT

• Kienitz R, Kay L, Beuchat I, Gelhard S, von Brauchitsch S, Mann C, Lucaciu A, Schafer JH, Siebenbrodt K, Zollner JP, Schubert-Bast S, Rosenow F, Strzelczyk A, Willems LM. Benzodiazepines in the Management of Seizures and Status Epilepticus: A Review of Routes of Delivery, Pharmacokinetics, Efficacy, and Tolerability. CNS Drugs. 2022 Sep;36(9):951-975. doi: 10.1007/s40263-022-00940-2. Epub 2022 Aug 16.

  PMID: 35971024 RESULT

• Amore M, D'Andrea M, Fagiolini A. Treatment of Agitation With Lorazepam in Clinical Practice: A Systematic Review. Front Psychiatry. 2021 Feb 22;12:628965. doi: 10.3389/fpsyt.2021.628965. eCollection 2021.

  PMID: 33692709 RESULT

• Yuen VM, Hui TW, Irwin MG, Yao TJ, Chan L, Wong GL, Shahnaz Hasan M, Shariffuddin II. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia. 2012 Nov;67(11):1210-6. doi: 10.1111/j.1365-2044.2012.07309.x. Epub 2012 Sep 5.

  PMID: 22950484 RESULT

• Baumgartner K, Groff V, Yaeger LH, Fuller BM. The use of dexmedetomidine in the emergency department: A systematic review. Acad Emerg Med. 2023 Mar;30(3):196-208. doi: 10.1111/acem.14636. Epub 2022 Dec 19.

  PMID: 36448276 RESULT

• Barends CRM, Driesens MK, Struys MMRF, Visser A, Absalom AR. Intranasal dexmedetomidine in elderly subjects with or without beta blockade: a randomised double-blind single-ascending-dose cohort study. Br J Anaesth. 2020 Apr;124(4):411-419. doi: 10.1016/j.bja.2019.12.025. Epub 2020 Feb 3.

  PMID: 32029262 RESULT

• Pastis NJ, Hill NT, Yarmus LB, Schippers F, Imre M, Sohngen W, Randall O, Callahan SP, Silvestri GA. Correlation of Vital Signs and Depth of Sedation by Modified Observer's Assessment of Alertness and Sedation (MOAA/S) Scale in Bronchoscopy. J Bronchology Interv Pulmonol. 2022 Jan 1;29(1):54-61. doi: 10.1097/LBR.0000000000000784.

  PMID: 34238838 RESULT

• Uusalo P, Seppanen SM, Jarvisalo MJ. Feasibility of Intranasal Dexmedetomidine in Treatment of Postoperative Restlessness, Agitation, and Pain in Geriatric Orthopedic Patients. Drugs Aging. 2021 May;38(5):441-450. doi: 10.1007/s40266-021-00846-6. Epub 2021 Mar 16.

  PMID: 33728561 RESULT

• Gupta A, Dalvi NP, Tendolkar BA. Comparison between intranasal dexmedetomidine and intranasal midazolam as premedication for brain magnetic resonance imaging in pediatric patients: A prospective randomized double blind trial. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):236-240. doi: 10.4103/joacp.JOACP_204_16.

  PMID: 28781452 RESULT

• Sinnott J, Holthaus CV, Ablordeppey E, Wessman BT, Roberts BW, Fuller BM. The Use of Dexmedetomidine in the Emergency Department: A Cohort Study. West J Emerg Med. 2021 Aug 22;22(5):1202-1209. doi: 10.5811/westjem.2021.4.50917.

  PMID: 34546899 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Lorazepam; Haloperidol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Butyrophenones; Ketones; Organic Chemicals

Study Officials

• William Paolo, MD

  State University of New York - Upstate Medical University

  STUDY CHAIR

Central Study Contacts

Jay M Brenner, MD

CONTACT

315-464-1861; brennerj@upstate.edu

Jaylan Hayes, PharmMD

CONTACT

315-464-9924; HayesJay@upstate.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: September 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share