Status:
COMPLETED
Sodium Lactate and Brain Relaxation (LSD)
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Sodium Lactate
Intracranial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 cerebra...
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 2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04488874
Start Date
September 29 2020
End Date
June 30 2023
Last Update
September 13 2023
Active Locations (1)
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1
CHU de Besançon
Besançon, France