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临床试验/NCT01065961
NCT01065961Unknown1 期

Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction

Albany Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
200
试验地点
1
主要终点
subjects will demonstrate good bony fusion

研究概览

简要总结

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.

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, Investigator)

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 of age or greater
  • Cervical spondylosis requiring surgical treatment at 2 or more motion segments
  • Ventrally - approachable vertebral levels

排除标准

  • Minors (under 18 years old)
  • Pregnant women
  • Patients currently taking steroids
  • Patients requiring surgical treatment at only one segment
  • Comatose or incapacitated patients who cannot consent to participate
  • Wards of the state
  • Persons with an allergy to dexamethasone or related drugs
  • Persons employed at Albany Medical Center

研究组 & 干预措施

Saline

Placebo Comparator

subject will be given a blinded dose of placebo saline intraoperatively followed by placebo doses every 6 hours for 24 hours.

干预措施: Saline (Drug)

Decadron

Active Comparator

Subject will be given Decadron 0.2mg/kg intraoperatively. This dose will be followed by 4 mg. every 6 hours for the first 24 hours.

干预措施: Decadron (Drug)

结局指标

主要结局

subjects will demonstrate good bony fusion

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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