Actively Recruiting
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients
Led by University Hospital, Grenoble · Updated on 2024-07-03
30
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation. This situation leads to a failure in controlling intracranial pressure (ICP) and/or to the risk of adverse effects due to high-dose sedatives: haemodynamic instability, prolonged mechanical ventilation, neuromyopathy, delirium, withdrawal syndrome. Halogenated agents (Isoflurane, Sevoflurane) are a class of hypnotics routinely used in the operating room. However, doses used in surgical patients (\> 1 Minimal Alveolar Concentration, MAC) are not suitable in neuro-intensive care unit (ICU) patients at risk of intracranial hypertension because of the cerebral vasodilator effects of halogenated agents at this dosage, hence the risk of high ICP and compromised cerebral perfusion pressure. The use of halogenated agents has been recently possible in the ICU through dedicated medical devices (Sedaconda ACD, Mirus). Recommended dosage are lower in the ICU, i.e. 0.3-0.7 MAC, because of their association with intravenous hypnotics and the absence of surgical stimuli. Several clinical studies in general ICUs showed improved sedation quality, reduced duration of mechanical ventilation, faster arousal and shorter extubation time, and lower costs in halogenated group compared with control group receiving midazolam or propofol. At low doses, the effects on ICP and intracerebral haemodynamics of halogenated agents are minor according to the available literature. In addition, beneficial effects were found on cerebral ischaemic volume in animal models treated with halogenated agents. However, there is a need to explore the benefit-risk ratio of the use of halogenated agents in the severe TBI population. The investigator hypothesise that 0.7 MAC Isoflurane can be administered in this population without deleterious effect on ICP.
CONDITIONS
Official Title
Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient older than 18 years
- Hospitalized in surgical intensive care for severe head trauma
- Receiving intravenous hypnotic therapy for at least 24 hours with at least two IV hypnotics and requiring continued sedation for at least 24 hours
- Richmond Agitation Sedation Scale (RASS) score between -3 and -5
- Initial intracranial pressure (ICP) less than 15 mmHg when starting isoflurane
- Functional intracranial pressure sensor in place
- Transcranial Doppler measurements done within 24 hours
- Written informed consent from legal representative, relative, or trusted person; emergency inclusion possible without consent
You will not qualify if you...
- History of decompressive craniectomy
- Personal or family history of malignant hyperthermia
- History of long QT syndrome
- Taking MAOI-type antidepressants (iproniazid or moclobemide)
- Known allergy to isoflurane or other volatile halogenated anesthetics
- Previous liver damage, jaundice, unexplained fever, or eosinophilia after halogenated anesthetic use
- Expected death within 24 hours
- Currently excluded from another clinical trial
- Inhaler device not available
- Protected persons under French law including pregnant women, women in childbirth, nursing mothers, persons deprived of liberty, or under legal protection
- No European social security coverage
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Trial Site Locations
Total: 1 location
1
University Hospital Grenoble
Grenoble, Choisir Une Région, France, 38043
Actively Recruiting
Research Team
B
barthélémy BERTRAND, MD
CONTACT
A
Anais ADOLLE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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