Assessing the prognosis of patients with extreme agitation in the emergency room
Official title: Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT
Run by Assistance Publique - Hôpitaux de Paris · NCT05632419 · Data updated 2026-11-12
This study looks at how patients with extreme agitation in the emergency room, especially those with emergence delirium, do over six months to see how many survive and how they feel afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 608 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny, Île-de-France Region) |
| Status | Recruiting |
| Started | January 17, 2023 |
| Main results expected | January 17, 2027 |
| Study ends | January 17, 2027 |
| Registry record updated | April 4, 2025 |
| Trial ID | NCT05632419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults presenting with extreme agitation characterized by specific clinical criteria.
✕Probably not a fit
Patients under 18 years of age, those with head trauma, pregnancy, or other obvious causes of agitation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the 6-month prognosis of patients who present with extreme agitation, specifically focusing on those experiencing emergence delirium. Patients will be assessed upon admission to the emergency room and followed up at one, three, and six months post-discharge to determine mortality rates. The study involves multiple centers across France and will include a total participation duration of six months for each patient. The research seeks to understand the morbidity and mortality associated with excited delirium syndrome.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the prognosis of agitated patients, potentially leading to improved management strategies in emergency settings.
How similar studies have gone: While the specific approach of this study may be novel, there is a growing body of literature addressing the outcomes of patients with extreme agitation, indicating potential for meaningful insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Agitated patient with the presence of three major criteria, namely, * restlessness * insensitivity to pain * tachypnea (fr\>20) and the presence of a minor criterion among * sweating * skin hyperthermia * non-compliance with law enforcement * tirelessness * unusual strength * inappropriate clothing, nudity Exclusion Criteria: * patient age \< 18 years * head trauma * pregnancy * detained * other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)
Where it's running
-
Avicenne Hospital - Aphp
Bobigny, Île-de-France Region, France Recruiting
Study contacts
- Principal investigator: Frédéric Adnet, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Frédéric Adnet, MD, PhD
- Email: frederic.adnet@avc.aphp.fr
- Phone: 01 48 96 44 08
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Oral vs IV Magnesium for Emergence Delirium in Children after Adenotonsillectomy
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Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children
This test compares dexmedetomidine plus midazolam against ketamine plus midazolam to see which better prevents emergence delirium in children having heart catheterization under general anesthesia.
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Remimazolam with sevoflurane to reduce wake-up agitation in children after neurosurgery.
This trial will test whether adding a single bolus of remimazolam to sevoflurane anesthesia lowers the chance that children ages 1–6 become agitated as they wake up from neurosurgery.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.