Effect of High Dose Steroids on Dysphagia After Anterior Spinal Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Soft tissue edema
研究概览
简要总结
Few existing data currently indicates that anti-inflammatory drugs could help diminish the local cervical inflammation tough to cause the dysphagia, hoarseness and dyspnea after an anterior surgical approach to the spine. This study aims to evaluate the effect of high dose of steroids on dysphagia after an anterior cervical spine procedure. Patients subjected to a cervical spine surgery through an anterior approach will be randomized to a treatment group receiving 3 doses of IV dexamethasone (decadron) and a placebo group receiving saline. Outcome will be measured with dysphagia scales, modified barium swallow and rhino-pharyngo-laryngoscopy, all done pre and post-operatively. Secondary outcomes involve neurological condition, pain and fusion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •Anterior cervical spine surgery
- •Elective surgery
排除标准
- •Takes steroids for any reason
- •Pre-existing condition leading to dysphagia
研究组 & 干预措施
Placebo group
Saline given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
干预措施: Placebo (Drug)
Treatment group
Dexamethasone, 4 mg IV given at 8 hours interval, first dose received at the time of surgery (induction), 3 doses total
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Soft tissue edema
时间窗: First day post-operatively
Pre-vertebral soft tissue edema on X Ray
Dysphagia evaluation: MBSimp
时间窗: First day post-operatively
Modified Barium Swallow with the calculation fof the MBSimp score
Voice evaluation
时间窗: First day post-operatively
Voice handicap index
Airway evaluation
时间窗: First day post-operatively
Rhino-Pharyngo-Laryngoscopy
Dysphagia evaluation: Rosenbeck
时间窗: First day post-operatively
Modified Barium Swallow with calculation of the Rosenbeck score
次要结局
- Fusion rate(6 months after surgery)
- Pain(3 months after surgery)
- Hyperreflexia(3 months post-operatively)
- Crude touch sensation(3 months after surgery)
- Strenght(3 months after surgery)
- Surgical site infection(3 months after surgery)