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临床试验/NCT00494832
NCT00494832已完成不适用

Influence of Dexmedetomidine on the Evoked Potentials During Spine Surgery

University of Washington2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in evoked potentials

研究概览

简要总结

The purposes of this study are:

  1. To evaluate the safety and efficacy of Dexmedetomidine as an adjunct for anesthesia during spine surgery and
  2. To investigate the influence of Dexmedetomidine on the evoked potentials.

详细描述

Use of evoked potentials can significantly improve neurologic outcome after major spine surgery. Modalities of evoked potentials commonly used are Somato-Sensory Evoked Potentials (SSEP's), Motor Evoked Potentials (MEP's), and Visual Evoked Potentials (VEP's).

Dexmedetomidine (DEX) is an alpha-2 agonist and has been FDA approved as an adjunct sedative agent to general anesthesia. It has been purported to reduce the amount of anesthetic required and potentiate the analgesic effect of opiates. In addition, DEX was shown to have minimal effect on SSEP's and VEP's in both rats and humans. Any decrease in the dose of general anesthesia that improves the monitoring of evoked potentials, supports DEX as an adjunct.

It is known that all anesthetic agents can interfere with the recording of evoked potentials. The choice of anesthetic however, depends on the modality of neurophysiologic monitoring planned for the patient. Total intravenous anesthesia (TIVA) and Sevoflurane, a low dose inhalational anesthetic are the usual agents for spine surgery. Both have a dose-related depressant effect on the quality of evoked potentials. As a result, it is common practice for the anesthesiologist to adjust the depth of anesthesia to improve signaling. The use of either anesthetic must accompany continuous infusion of Propofol and an opioid, Remifentanil or Fentanyl. The anesthesiologist then decides whether DEX should be as an adjunct. In our experience, DEX did not impair evoked potentials. In fact, it improved the quality of signals in a few patients. Yet, there are no published data of such effects in medical literature.

We hypothesize that Dexmedetomidine will not influence evoked potentials when used as an adjunct to general anesthesia. Our study is prospective, randomized, double-blinded and will be carried out on a set of anesthetics. We will first evaluate DEX as an adjunct in TIVA, then as an adjunct to Sevoflurane. The probable benefit of DEX may avoid the use of potent inhaled anesthetics which would improve VEP's monitoring. Quality recording of evoked potentials can enhance our ability to detect iatrogenic injury to the spinal cord and vision.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult spine surgery patients requiring evoked potentials monitoring.

排除标准

  • Age younger than 18 and older than 80 years
  • Patients with moderate neurological deficit
  • ASA grade above 3
  • Any chronic psychiatric disorder
  • Body mass index (BMI) above 35
  • Patients with cortical blindness, cataracts, retinal or optic neuropathy, glaucoma, untreated diabetes, active hepatitis, active coronary artery disease, untreated arrhythmias and patients with renal or hepatic insufficiency

研究组 & 干预措施

Dexmedetomidine

Active Comparator

Dexmedetomidine infusion

干预措施: Dexmedetomidine (Drug)

Placebo

Placebo Comparator

Normal Saline infusion

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in evoked potentials

时间窗: Duration of surgery

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 (2)

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