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Study identifier: NCT06311604 Synced from ClinicalTrials.gov · July 28, 2026
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Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients

Condition: Traumatic Brain Injury  ·  Sponsor: University Hospital, Grenoble

PhaseNA
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 mech…

This description comes directly from the study's public registry record.

Talk to the study team

barthélémy BERTRAND, MD  ·  +33 476766879  ·  bbertrand4@chu-grenoble.fr

Anais ADOLLE  ·  +33 476766879  ·  aadolle@chu-grenoble.fr

Always discuss trial participation with your own doctor first.

Locations (1)

University Hospital GrenobleGrenoble, Choisir Une Région, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06311604