Using inhaled isoflurane for sedation in patients with severe head trauma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety of using inhaled isoflurane as a sedation method for patients suffering from severe traumatic brain injury (TBI). The study aims to address the challenges associated with intravenous sedatives, which can lead to tolerance and adverse effects. By administering isoflurane at lower doses in a controlled ICU environment, the researchers hope to maintain effective sedation while minimizing risks related to intracranial pressure. The trial involves monitoring patients' intracranial pressure and sedation levels over a specified period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient \> 18 years old
* Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
* On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours, with a RASS of between -3 and -5
* Initial ICP \< 15 mmHg on introduction of isoflurane
* Functional intracranial pressure sensor
* Transcranial Doppler measurements performed within 24 hours
* Written informed consent from a legal representative/relative/trusted person. In the absence of a legal representative, the patient may be included under the emergency procedure.

Exclusion Criteria:

* Patients who have had a decompressive craniectomy
* Patients with a personal or family history of malignant hyperthermia
* Patients with a history of long QT syndrome
* Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
* Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
* Patients who have experienced liver damage, jaundice, unexplained fever, or eosinophilia after administration of a halogenated anaesthetic.
* Patients expected to die within the next 24 hours
* Subject in a period of exclusion from another clinical trial,
* Technical unavailability of the inhaler
* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
* No European social security

Where it's running

• University Hospital Grenoble
  Grenoble, Choisir Une Région, France Recruiting

Study contacts

• Principal investigator: barthélémy BERTRAND, MD — University Hospital, Grenoble
• Study coordinator: barthélémy BERTRAND, MD
• Email: bbertrand4@chu-grenoble.fr
• Phone: +33 476766879

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.