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Altered Mental StatusPhase 3NCT06370442

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

A Phase 3 study testing Dexmedetomidine, Lorazepam and Haloperidol in people with Altered Mental Status, run by State University of New York - Upstate Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Altered Mental Status
What is being tested?
Dexmedetomidine, Lorazepam and Haloperidol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

No sites are listed yet.

Jay M Brenner, MD contact

315-464-1861

brennerj@upstate.edu

Jaylan Hayes, PharmMD contact

315-464-9924

HayesJay@upstate.edu

About this study

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).

Being tested
Dexmedetomidine, Lorazepam, Haloperidol
Keywords
Sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Precedex

    Intranasal dexmedetomidine, 100mcg

  • LorazepamDrug

    Also called Ativan

    0.5mg IV

  • HaloperidolDrug

    Also called Haldol

    0.5mg IV

Study groups in NCT06370442
Study groupRoleWhat they receive
LorazepamActive comparatorNot described
Receives: Drug: Lorazepam
HaloperidolActive comparatorNot described
Receives: Drug: Haloperidol
IN DexExperimentalNot described
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within one hour of administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion31 May 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06370442
Sponsor's protocol ID
2137695
Status last verified
Apr 2024
First submitted
12 Apr 2024
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34820831

  • 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.

    PubMed 22144928

  • 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.

    PubMed 35971024

  • 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.

    PubMed 33692709

  • 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.

    PubMed 22950484

  • 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.

    PubMed 36448276

  • 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.

    PubMed 32029262

  • 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.

    PubMed 34238838

  • 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.

    PubMed 33728561

  • 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.

    PubMed 28781452

  • 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.

    PubMed 34546899

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexmedetomidine, Lorazepam and Haloperidol in people with Altered Mental Status, run by State University of New York - Upstate Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jay M Brenner, MD (315-464-1861, brennerj@upstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation (time frame: Within one hour of administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06370442, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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