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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of brain relaxation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will not known which of Sodium lactate or Mannitol will they receive. The drug will be hidden by an opaque drape during its administration and as soon as the administration is over it will be taken out of the operating room, so the neurosurgeon won't know which drug was given.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Sodium Lactate
Intravenous Molar Sodium Lactate is administered during the first surgical incision. The dose is 2.5mL/kg.
干预措施: Sodium Lactate (Drug)
Mannitol 20%
Intravenous mannitol 20% is administered during the first surgical incision. The dose is 5mL/kg (1g/kg).
干预措施: Mannitol 20% Infusion (Drug)
结局指标
主要结局
Quality of brain relaxation
时间窗: intraoperative
An adequate brain relaxation is evaluated by the neurosurgeon with a stage 1 (perfectly relaxed) or 2 (acceptably relaxed) of the brain swelling score validated by Todd et al. The brain swelling score is a four-point-scale: 1 (normal brain; no swelling); 2 (minimal swelling, but acceptable); 3 (serious swelling but no specific change in management required); or 4 (severe brain swelling requiring some intervention). Todd et al. reported a significant Relationship between intracranial pressure and the brain swelling score. The brain swelling score is the consensual tool used in clinical trials to assess the clinical effectiveness of brain relaxative therapy.
次要结局
- Necessity for "rescue" therapy(intraoperative)
- Changes of lactatemia(30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion)
- Volume of post operative brain edema(Day 2 after surgery)
- Electrolytes alterations(30 minutes, 60 minutes, 180 minutes, 24 hours and 48 hours after completion of sodium lactate or mannitol infusion)
- Extubation(Within 2 hours after the end of surgery)
- 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)
- 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)
- Glasgow Coma Scale(preoperative, at day 1 and day 2 postoperative)
- Neurological recovery(preoperative and Day 2 after surgery)
- 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)
- Morbidity(Within 30 days after surgery)
- Mortality(Within 30 days after surgery)
- Karnofsky performance scale(preoperative and at day 30 after surgery)