Effect of Intravenous Corticosteroid Injections on Dysphagia After Anterior Cervical Spine Surgery: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Intravenous Corticosteroids Effect on Post-operative Dysphagia
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.
详细描述
The purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. This study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. Furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. Finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. Secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects included in the study are patients undergoing an anterior cervical spine procedure.
排除标准
- •Patients with greater than ASA grade II will be excluded. Patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. Patients with posterior procedures will be excluded. Patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the EAT-10 questionnaire,19 will also be excluded. Patients who are pregnant will be excluded from this study.
研究组 & 干预措施
Dexamethasone
Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
干预措施: Dexamethasone (Drug)
Saline
Subject will receive doses of intravenous physiological saline solution.
干预措施: Saline (Other)
结局指标
主要结局
Intravenous Corticosteroids Effect on Post-operative Dysphagia
时间窗: 12 months
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.
时间窗: 12 months
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
次要结局
- Examine the Impact of Dexamethasone on Radicular Pain.(12 months)
- Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.(Immediate post-operatively)
- Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.(12 months)
- The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.(12 months)