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