Sodium Lactate and Brain Relaxation (LSD)

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 29, 2020

Primary Completion Date

May 31, 2023

Study Completion Date

June 30, 2023

Conditions
Sodium LactateIntracranial HypertensionBrain Relaxation
Interventions
DRUG

Sodium Lactate

"Sodium lactate is administered at 2.5mL/kg during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.~Sodium Lactate and Mannitol 20% are used at an equimolar dose"

DRUG

Mannitol 20% Infusion

Mannitol 20% is administered intravenously at a dose of 5mL/kg, so 1g/kg, during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.

Trial Locations (1)

Unknown

CHU de Besançon, Besançon

All Listed Sponsors
lead

Centre Hospitalier Universitaire de Besancon

OTHER

NCT04488874 - Sodium Lactate and Brain Relaxation (LSD) | Biotech Hunter | Biotech Hunter