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临床试验/NCT03823482
NCT03823482Unknown不适用

Effect of Regional Anesthesia With Lidocaine on Perioperative Levels of Interleukin-1β, Interleukin-6 and Tumor Necrosis Factor-α in Blood and Cerebrospinal Fluid in Cerebral Aneurysm Patients

Clinical Hospital Centre Zagreb1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Change in concentrations of interleukin-1β

研究概览

简要总结

Cerebral aneurysm surgery has significant mortality and morbidity rate. Inflammation plays a key role in the pathogenesis of intracranial aneurysms, their rupture, subarachnoid haemorrhage and neurologic complications. Brain injury activates immune cells and triggers cytokine release. Cytokine level in blood and cerebrospinal fluid is an indicator of inflammatory response. Cytokines contribute to secondary brain injury and can worsen the outcome of the treatment. Preventing secondary brain injury by modulating inflammatory response represents a therapeutic target. Lidocaine is local anesthetic that can be used in neurosurgery for regional anesthesia of the scalp and for topical anesthesia of the throat prior to direct laryngoscopy and endotracheal intubation. Except analgetic, lidocaine has systemic anti-inflammatory and neuroprotective effect. It acts through several mechanisms on various types of immune cells producing immunosuppressing effect. Lidocaine can act on activated microglia within central nervous system causing attenuation of immune response.

Primary aim of this prospective randomized trial is to determine influence of lidocaine administration on inflammatory cytokine levels in serum and cerebrospinal fluid during and following cerebral aneurysm surgery. Secondary aim is to determine possible correlation between levels of cytokines and incidence of neurologic and infectious postoperative complications. For that purpose, postoperative neurological clinical status will be recorded. Signs of vasospasm and pathological postoperative brain CT scan findings will be recorded. Incidence of meningitis, pneumonia and sepsis in postoperative period will also be analyzed.

Hypothesis of this trial is that lidocaine administration during cerebral aneurysm surgery would significantly change levels of pro-inflammatory cytokines in cerebrospinal fluid and serum. Lower concentrations of pro-inflammatory cytokines can possibly contribute to better outcome and significantly lower incidence of postoperative complications. Enzyme-immunochemical analysis will be used to measure levels of interleukin-1β, interleukin-6 and tumor necrosis factor-α in cerebrospinal fluid and serum. Investigation group will have, during cerebrovascular surgery under general anesthesia, regional anesthesia of the scalp and topical anesthesia of the throat prior to laryngoscopy, all done with lidocaine. Control group will have general anesthesia without lidocaine administration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA ( American Society of Anesthesiologists) grading status I-III,
  • scheduled for cerebral aneurysm surgery under general anesthesia,
  • signed informed consent for participating in the research.

排除标准

  • poorly controlled chronic or acute cardiovascular, respiratory or autoimmune disease,
  • acute infectious disease,
  • renal or hepatic insufficiency,
  • preoperative Glasgow Coma Scale score lower than 15,
  • allergic reaction to any of the medications in protocol,
  • pregnancy
  • refusal to participate in the research.

研究组 & 干预措施

Lidocaine group

Experimental

Participants in lidocaine group, following induction to general anesthesia, will have lidocaine 2% 4 mg/kg administered as regional anesthesia of the scalp prior to Mayfield frame placement and lidocaine 1% 40 mg topically to the throat prior to direct laryngoscopy and endotracheal intubation. Maximum dosage of lidocaine won't exceed 400 mg.

干预措施: Lidocaine (Drug)

结局指标

主要结局

Change in concentrations of interleukin-1β

时间窗: Up to 24 hours after anesthesia induction.

Concentrations of IL-1β in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

Change in concentrations of tumor necrosis factor α

时间窗: Up to 24 hours after anesthesia induction.

Concentrations of TNF-α in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

Change in concentrations of interleukin-6

时间窗: Up to 24 hours after anesthesia induction.

Concentrations of IL-6 in pg/ml in cerebrospinal fluid and serum measured by enzyme-linked immunosorbent assay

次要结局

  • Incidence of new motoric deficit(Up to one week postoperatively)
  • Incidence of vasospasm(Up to one week postoperatively)
  • Incidence of generalized epileptic seizure(Up to one week postoperatively)
  • Incidence of pathological computerized tomography brain scan(Up to one week postoperatively)

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marijana Matas

Principal Investigator

Clinical Hospital Centre Zagreb

研究点 (1)

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