Clinical trial · Interventional
Sodium Lactate and Brain Relaxation (LSD)
Clinical Effectiveness of Hypertonic Sodium Lactate Infusion for Intraoperative Brain Relaxation in Patients Undergoing Scheduled Craniotomy for Supratentorial Brain Tumor Resection: Study Protocol of a Single Center Double-blind Randomized Controlled Phase II Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Relaxation | — | UNRESOLVED | — |
| Intracranial Hypertension | — | UNRESOLVED | — |
| Sodium Lactate | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mannitol 20% Infusion | Drug | — | UNRESOLVED |
| Sodium Lactate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sodium Lactate
- description
- Intravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg.
- interventionNames
- Drug: Sodium Lactate
- type
- ACTIVE_COMPARATOR
- label
- Mannitol 20%
- description
- Intravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg).
- interventionNames
- Drug: Mannitol 20% Infusion
Primary outcomes (1)
- measure
- Quality of brain relaxation
- timeFrame
- intraoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with ASA 1, ASA 2 ou ASA 3, meaning they don't have any unstable comorbidities which could be a threat to life. * Scheduled surgery for resection of supratentorial brain tumors by craniotomy under general anesthesia * Unilateral brain tumor * Deviation of the falx cerebri \> 3mm on the preoperative imaging * Pharmacological brain relaxation required by the neurosurgeon in charge of the patient. * Patient who has been informed and who signed the free informed consent to participate to the study. Meaning the patient understood the purpose and the procedures required by the study and agreed to participate and obey the requirements and restrictions of this study. * Affiliation to a social security system or recipient of a such system. Exclusion Criteria: * Emergency surgery * Age \< 18 years old or \> 75 years old * ASA score IV-V * Legal incapability or limited legal capacity * Patient who will unlikely cooperate to the study and/or poor cooperation foreseen by the investigator * Preoperative Glasgow score \< 13 * Pregnant woman and/or breastfeeding * Body index masse\< 18 kg.m-2 ou \> 30 kg.m-2 * Preoperative hyponatremia \< 130mmol/l or hypernatremia \> 145 mmol/l * Osmotherapy in the 24 hours prior to the surgery (Mannitol, Hypertonic saline, Sodium lactate) * Congestive heart failure * Moderate ou severe chronic kidney disease, defined by a creatinine clearance (MDRD) \< 60 ml/min * End-stage liver disease (Child Pugh ≥ B7) * Myasthenia gravis * External ventricular drain or ventriculoperitoneal shunt of cerebrospinal fluid * Allergy to Mannitol 20% or one of his excipients * Allergy to Sodium Lactate or one of his excipients * Contraindication for propofol * Allergy to anesthetic agents (propofol, remifentanil, cisatracurium) * Refusal of consent * Patient within the exclusion period of another study or planned by the "national file of volunteers" * Medical history of cognitive disorders or demencia
References
Publications (3)
- BACKGROUNDTodd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002. PMID 8512094
- DERIVEDBesch G, Thines L, Bronnert R, Boitel A, Scaringella N, Hammoudi F, Hamdan N, Charpentier H, Villeneuve J, Clairet AL, Vettoretti L, Ferreira D, Berthier F, Pili-Floury S. Clinical effectiveness of intravenous hypertonic sodium lactate infusion for intra-operative brain relaxation in supratentorial brain tumour surgery: A double-blind randomised phase II pilot study. Eur J Anaesthesiol. 2026 May 8. doi: 10.1097/EJA.0000000000002414. Online ahead of print. PMID 42109031
- DERIVEDBesch G, Parmentier AL, Berthier F, Jaeg H, Villeneuve J, Hammoudi F, Scaringella N, Clairet AL, Vettoretti L, Chopard G, Thines L, Ferreira D, Samain E, Pili-Floury S. Clinical effectiveness of hypertonic sodium lactate infusion for intraoperative brain relaxation in patients undergoing scheduled craniotomy for supratentorial brain tumor resection: A study protocol of a single center double-blind randomized controlled phase II pilot trial. Medicine (Baltimore). 2022 Oct 7;101(40):e31038. doi: 10.1097/MD.0000000000031038. PMID 36221362