Sodium Lactate & Brain Relaxation (LSD)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04488874
Study type	Interventional
Source	Centre Hospitalier Universitaire de Besancon
Contact
Status	Completed
Phase	Phase 3
Start date	September 29, 2020
Completion date	June 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06367868` - Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring	N/A
Not yet recruiting	`NCT04211064` - Comparison of the Effects of Deep and Moderate Neuromuscular Blockade on Optic Nerve Sheath Diameter	N/A
Completed	`NCT00571623` - Automated Chest Physiotherapy to Improve Outcomes in Neuro	N/A
Recruiting	`NCT00437814` - Effect of Ketamine (Ketalar) on Intracranial Pressure	N/A
Recruiting	`NCT03212976` - Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure	N/A
Withdrawn	`NCT02558309` - Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure	N/A
Terminated	`NCT00795587` - Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring	Phase 4
Completed	`NCT00447018` - Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure	Phase 4
Not yet recruiting	`NCT05593380` - The Effect of BIA Monitoring of Brain Edema on the Neurological Prognosis of Supratentorial Massive ICH	N/A
Completed	`NCT03364634` - Intracranial Pressure After Decompressive Craniectomy	N/A
Unknown status	`NCT02773901` - Comparison of the Non-invasive ICP HeadSense Monitor vs Lumbar CSF Pressure Measurement	N/A
Terminated	`NCT01973764` - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System	N/A
Terminated	`NCT00319345` - Sodium-Lactate and Traumatic Brain Injury	Phase 2/Phase 3
Recruiting	`NCT04459806` - Intracranial PrEssure Time dOse (ImPETO)
Completed	`NCT00239525` - 3-D Transcranial Ultrasound Analysis Study	N/A
Completed	`NCT05946200` - Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia	N/A
Completed	`NCT03957837` - Optical Nerve Sheath Changes During Head Down Laparoscopy
Not yet recruiting	`NCT05818371` - Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting	N/A
Completed	`NCT04429477` - Cerebral Compliance Impairment in COVID-19
Recruiting	`NCT03144219` - A Novel Non-invasive Technique of Cerebral Compliance and Auto-regulation Assessment

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sodium Lactate and Brain Relaxation (LSD) — LSD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms