Sodium Lactate and Brain Relaxation (LSD)
Condition: Sodium Lactate; Intracranial Hypertension; Brain Relaxation
MeSH terms: Intracranial Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Resection surgery of brain tumors by craniotomy requires efficient brain relaxation
      intraoperatively in order to avoid injuries caused by the brain retractors (such as
      ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during
      a surgery is Mannitol 20%.

      Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain
      injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of
      sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may
      participate to the reduction of cerebral oedema and secondary injuries.

      LSD is a pilot randomised trial which tries to assess the interest of intravenous
      administration of molar Sodium Lactate on the quality of brain relaxation in surgical
      resection of supratentorial brain tumors by craniotomy.

      The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at
      the opening of the dura, by a validated brain relaxation scale.
    

Detailed description: 
      It's a prospective, comparative, randomised, double blinded study. It will enroll 50 patients
      undergoing resection surgery of supratentorial brain tumor. They will be randomly divided in
      2 groups of 25 patients each : Mannitol 20% and molar Sodium Lactate. The only difference
      between the 2 groups is the drug used for brain relaxation at the surgical incision :
      Mannitol or Sodium lactate.

      The outcome measures include quality of brain relaxation, need of "rescue" therapy to get an
      adequate brain relaxation, electrolytes alterations, change in lactate serum level,
      quantification of post operative brain swelling by MRI, time of extubation, Glasgow Coma
      Scale, neuropsychological evaluation, blood levels of Protein S100-β, NSE (Neuron-Specific
      Enolase) and GFAP Glial Fibrillary Acid Protein), morbidity and mortality during 30 days
      after surgery.
    

Intervention name(s): Sodium Lactate; Mannitol 20% Infusion
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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.
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain relaxation; Sodium lactate; Mannitol 20%; Neurosurgery