Using inhaled isoflurane for sedation in patients with severe head trauma
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Patients With Severe Traumatic Brain Injury
This study is testing if using inhaled isoflurane for sedation can safely help patients with severe head injuries without the risks of traditional sedatives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble, Choisir Une Région) |
| Trial ID | NCT06311604 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are hospitalized in surgical intensive care for severe head trauma and require prolonged sedation.
Not a fit: Patients who have undergone decompressive craniectomy or have specific contraindications such as malignant hyperthermia or long QT syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective sedation method for patients with severe head trauma.
How similar studies have performed: While the use of inhaled halogenated agents in ICU settings is less common, there is potential for success based on their established use in anesthesia, though this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Grenoble, Choisir Une Région
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.