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

Altered Mental Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06370442
• Other study ID #: 2137695
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: State University of New York - Upstate Medical University
• Contact: Jay M Brenner, MD
• Phone: 315-464-1861
• Email: brennerj[@]upstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Altered Mental Status
• Emergencies

Intervention

Drug:
• Dexmedetomidine
Intranasal dexmedetomidine, 100mcg
• Lorazepam
0.5mg IV
• Haloperidol
0.5mg IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 Ro — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 202 — View Citation

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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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