Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult
NCT ID: NCT06370442
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2024-06-01
2025-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Lorazepam
Lorazepam
0.5mg IV
Haloperidol
Haloperidol
0.5mg IV
IN Dex
Dexmedetomidine
Intranasal dexmedetomidine, 100mcg
Interventions
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Dexmedetomidine
Intranasal dexmedetomidine, 100mcg
Lorazepam
0.5mg IV
Haloperidol
0.5mg IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in need of sedation prior to either a computerized tomography (CT) or magnetic resonance imaging (MRI)
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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State University of New York - Upstate Medical University
OTHER
Responsible Party
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Jay Brenner
Professor
Principal Investigators
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William Paolo, MD
Role: STUDY_CHAIR
State University of New York - Upstate Medical University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2137695
Identifier Type: -
Identifier Source: org_study_id
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