Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 20, 2024

Primary Completion Date

June 20, 2026

Study Completion Date

March 20, 2027

Conditions
Traumatic Brain Injury
Interventions
DRUG

Isoflurane

"Inclusions will have 4 phases according to gradual increased doses of isoflurane:~Phase 1: Inclusion of 3 patients with 0.3 MAC isoflurane. In the absence of an increase of ICP \> 20% from baseline, inhaled sedation is maintained for 24 hours until the primary endpoint is assessed. If there one patient who does not tolerate this threshold, three additional patients will be included in this phase. A maximum of one treatment failure (see definition below) is tolerated in the phase 1~Phase 2: Inclusion of 3 additional patients with isoflurane dosage of 0.5 MAC under the same conditions as phase 1.~Phase 3: Inclusion of 3 additional patients with isoflurane dosage of 0.7 MAC under the same conditions as phases 1 and 2.~Phase 4: Inclusion of 12-15 additional patients will be included at the 0.7 MAC dose, to have 18 patients exposed to 0.7 MAC isoflurane."

Trial Locations (1)

38043

RECRUITING

University Hospital Grenoble, Grenoble

All Listed Sponsors
lead

University Hospital, Grenoble

OTHER

NCT06311604 - Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients | Biotech Hunter | Biotech Hunter