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Can a common sedative calm ICU delirium without a breathing tube?

NCT ID NCT03317067

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the sedative dexmedetomidine can reduce how long non-intubated ICU patients experience agitated delirium. Researchers randomly gave 168 patients either dexmedetomidine or a placebo. The goal was to see if the drug shortens agitation and delirium, and reduces the need for breathing tubes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dexmedetomidine
What this could lead to
If it works, this could offer a way to calm agitated ICU patients without needing a breathing tube, potentially shortening their hospital stay.
What could go wrong
This is a relatively small, early-phase trial, so results may not apply to all ICU patients. Dexmedetomidine can cause low blood pressure or slow heart rate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

168 people

The number who actually took part.

Started

Dec 2017

Finished

Feb 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * • Age \> 18 years * Patient hospitalized in an ICU * Presenting a productive delirium according to the following criteria: * acute onset (\<2h) and fluctuating course during the same day * alteration of cognitive functions: disorganization of thought (delirium of persecution, inability to reason logically), abnormal perceptions (hallucinations), memory impairments, temporal disorientation, non- or misrecognitions, difficulties in naming objects or writing) * in whom a simple cropping and non-medicated therapeutics are not sufficient to allow symptoms' resolution for few hours * CAM-ICU positive AND a RASS \> +1 * Non-intubated or extubated (\> 24h) * No contraindication of dexmedetomidine or haloperidol uses Exclusion Criteria: * • Age \<18 years * Administration of dexmedetomidine and/or clonidine during the 72 hours before inclusion * Contraindication to the use of Dexmedetomidine, clonidine or haloperidol (history of allergy, Parkinson's disease, oro-pharyngeal dysfunction, arterial hypotension or bradycardia, QTc interval prolongation, and hepatic or renal dysfunction), as mentioned in the Summaries of Product Characteristics * Neuropsychiatric pathology judged by the investigator as a potential source of bias (in particular: active drug addiction, psychosis...) * Parturient or breast-feeding woman * Protected major (guardianship) * Patient's or relative's refusal to participate

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Conditions

The condition(s) this trial relates to.

delirium Psychomotor Agitation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Agitation Delirium

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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