Impact of Single Dose Perioperative Steroids on Dysphagia Following Anterior Cervical Spine Surgery: A Randomized, Prospective, Double-Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in the Occurrence of Dysphagia -Bazaz Scale
研究概览
简要总结
This prospective, randomized, double blind, controlled study evaluates the effect of a single dose of perioperative IV steroid versus saline on swallowing after anterior cervical spine surgery
详细描述
This investigation is a prospective, randomized, double-blind, controlled trial testing a single dose of peri-operative steroid versus saline and the effect on swallowing after anterior cervical spine surgery.
Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale, the EAT10 survey, 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)
盲法说明
Double blinded (participant and 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
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 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 single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
干预措施: Dexamethasone (Drug)
Treatment 0; Placebo
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, 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 a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
干预措施: Saline (Drug)
结局指标
主要结局
Change in the Occurrence of Dysphagia -Bazaz Scale
时间窗: Baseline to Month 6
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
时间窗: Baseline to Month 12
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
时间窗: Baseline to Month 12
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
次要结局
未报告次要终点
研究者
Scott Daffner
Associate Professor, MD
West Virginia University