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临床试验/NCT00671931
NCT00671931已完成1 期

Susceptibility of Motor-Evoked Potentials to Varying Targeted Blood Levels of Dexmedetomidine

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
44
试验地点
1
主要终点
Motor Evoked Potential Amplitude

研究概览

简要总结

Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response.

Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
盲法
None

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects must be 10 to 25 years of age
  • Diagnosis of idiopathic scoliosis is established
  • Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate
  • American society of Anesthesiology physical status one/two
  • Patients scheduled for posterior spinal fusion only

排除标准

  • • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities
  • Patients with allergy to, or contraindication for the drugs or techniques used in the study
  • Morbid obesity (Body mass index higher than 40)
  • History of malignant hyperthermia
  • Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)

研究组 & 干预措施

II

Active Comparator

Dexmedetomidine high infusion, Propofol low infusion

干预措施: high dexmedetomidine, low propofol (Drug)

I

Active Comparator

Dexmedetomidine low infusion, Propofol low infusion

干预措施: low dexmedetomidine, low propofol (Drug)

IV

Active Comparator

Dexmedetomidine high infusion, Propofol high infusion

干预措施: Dexmedetomidin (Drug)

V

Active Comparator

Dexmedetomidine intermediate infusion, Propofol intermediate infusion

干预措施: Dexmedetomidine (Drug)

III

Active Comparator

Dexmedetomidine low infusion, Propofol high infusion

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Motor Evoked Potential Amplitude

时间窗: baseline, 30 minutes

The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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