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临床试验/NCT02232347
NCT02232347Unknown2 期

Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study

Pierre-Julien CUNGI1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年10月最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
20
试验地点
1
主要终点
brain glutamate concentrations

研究概览

简要总结

The objective of the study is to compare the effects of 48 hours ketamine infusion versus sufentanil infusion on brain glutamate concentrations measured with microdialysis after traumatic brain injury.

We hypothesize that ketamine infusion will decrease high glutamate values faster than sufentanil.

详细描述

Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare the effects of ketamine versus sufentanil on brain glutamate concentrations measured with microdialysis.

Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in more than 60% of the severe head trauma patients. It induces cortical spreading depression which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care units for sedation and induction of anesthesia. It's the recommended medication for induction of unstable wounded soldiers on the field because of its neutrality on haemodynamic state.

Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension which is deleterious for cerebral perfusion pressure after brain trauma.

In our unit, patients with severe head injury are monitored by a triple lumen access device including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and microdialysis. This last monitoring allows measurement of brain parenchymal concentrations of small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to evaluate the metabolic state of the brain divided into 4 categories : normal, hyperglycolysis, ischemia and metabolic crisis.

Then, we will detail the effects of ketamine on metabolic state of the brain, especially glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24 hours. Ketamine is expected to decrease these high values faster than described in observational studies.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • > 18 years old
  • Glasgow Coma Scale (GCS) < 9
  • > 3 days of sedation expected at the arrival

排除标准

  • pregnancy
  • < 18 years old
  • estimated survival < 48 hours post-trauma
  • expected sedation < 3 days
  • coagulation impairment (platelets<100.000/mm3 and prothrombin time (TP) <60%)
  • Cardiac arrest before ICU admission
  • Admission > 12 hours after trauma
  • Multimodal monitoring implanted > 24 hours post trauma
  • Participation to the study refused by the next of kind
  • No next of kind

研究组 & 干预措施

ketamine

Experimental

ketamine 5 mg/kg/h, continuous infusion for 48 hours

干预措施: Ketamine (Drug)

sufentanil

Active Comparator

sufentanil 0,5 mcg/kg/h, continuous infusion for 48 hours

干预措施: Sufentanil (Drug)

结局指标

主要结局

brain glutamate concentrations

时间窗: H0-H12, H12-H24, H24-H36 and H36-H48

To compare the kinetic of brain glutamate concentration decrease during 4 periods of 12 hours between ketamine infusion group (KET) and sufentanil standard infusion group (STD)

次要结局

  • metabolic profile(H0-H12, H12-H24, H24-H36 and H36-H48)
  • Episodes of intracranial hypertension (ICHT) and brain ischemia(H0-H12, H12-H24, H24-H36 and H36-H48)
  • Therapeutic Intensity Level (TIL)(Days 1 and 2)
  • Glasgow Outcome Scale (GOS) et extended Glasgow Outcome Scale (eGOS)(6 months and 1 year)

研究者

发起方
Pierre-Julien CUNGI
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre-Julien CUNGI

MD

Direction Centrale du Service de Santé des Armées

研究点 (1)

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