The Effects of Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Swallowing Difficulty
研究概览
简要总结
This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
详细描述
This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •Elective anterior approach to subaxial cervical spine (C3 - T1);
- •ages 18-80
排除标准
- •Traumatic or tumor etiologies
- •undergoing anterior-posterior operations
- •neoplastic, or infectious conditions requiring surgery
- •a history of previous anterior cervical spine surgery
- •any patient requiring a halo vest
- •patients on chronic steroids
- •patients remaining intubated post-operatively (please see more under risks below)
- •less than 18 years of age
- •pregnant women
研究组 & 干预措施
Treatment 1; Dexamethasone
Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.
干预措施: Treatment 1; Dexamethasone (Drug)
Treatment 0; Saline placebo
Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.
干预措施: Treatment 0; Saline placebo (Drug)
结局指标
主要结局
Swallowing Difficulty
时间窗: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months
Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.
次要结局
- Fusion Rate Steroid vs Placebo(1 year)
- Change in Quality of Life(Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.)
研究者
Sanford E Emery, MD, MBA
Professor and Chair West Virginia University Department of Orthopaedics
West Virginia University