Sodium Lactate and Brain Relaxation (LSD)
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 11/30/2019 |
| Primero enviado: | 04/07/2019 |
| Inscripción estimada enviada: | 07/23/2020 |
| Publicado por primera vez: | 07/27/2020 |
| Última actualización enviada: | 07/23/2020 |
| Última actualización publicada: | 07/27/2020 |
| Fecha de inicio real del estudio: | 09/14/2020 |
| Fecha estimada de finalización primaria: | 03/31/2021 |
| Fecha estimada de finalización del estudio: | 09/30/2021 |
Condición o enfermedad
Intervención / tratamiento
Drug: Sodium Lactate
Drug: Mannitol 20%
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Sodium Lactate Intravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg. | 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 |
| Active Comparator: Mannitol 20% Intravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg). | Drug: Mannitol 20% 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. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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 |
Salir
Medidas de resultado primarias
1. Quality of brain relaxation [intraoperative]
Medidas de resultado secundarias
1. Necessity for "rescue" therapy [intraoperative]
2. Electrolytes alterations [30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion]
3. Changes of lactatemia [30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion]
4. Volume of post operative brain edema [Day 2 after surgery]
5. Glasgow Coma Scale [preoperative, at day 1 and day 2 postoperative]
6. Extubation [Within 2 hours after the end of surgery]
7. Neurological recovery [preoperative and Day 2 after surgery]
8. Protein S100-β [Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion]
9. Neuron-Specific Enolase (NSE) [Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion]
10. Glial Fibrillary Acid Protein (GFAP) [Prior to sodium lactate or mannitol infusion and at 24 hours and at 48 hours after completion of sodium lactate or mannitol infusion]
11. Morbidity [Within 30 days after surgery]
12. Mortality [Within 30 days after surgery]
13. Karnofsky performance scale [preoperative and at day 30 after surgery]
