The Effects of 3% Sodium Chloride on Post-operative Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: a Prospective, Randomized Double-blind Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Post-operative dysphagia
研究概览
简要总结
Post-operative dysphagia is a significant issue following anterior cervical spine surgery. The investigators are studying the effects of perioperative 3% sodium chloride, given over a period of 24 hours, on post-operative dysphagia. The goal is to reduce the incidence and severity of post-operative dysphagia.
详细描述
Based on a priori analysis the investigators will need 100 subjects in a placebo arm (normal saline) and 100 subjects in a treatment arm (3% sodium chloride), for a total of 200 patients. This study will be conducted on healthy subjects with normal renal function undergoing anterior cervical discectomy and fusion for degenerative indications only. Subjects will be randomized to the treatment or placebo arm (which will be double blinded). Subjects in the treatment arm will begin to receive intravenous 3% sodium chloride before the incision is made. The solution will be given at a rate of 10 cc/hour over a period of 24 hours. Baseline, post-operative, and delayed post-operative dysphagia surveys will be administered either in person or by telephone. The investigators hope to decrease the incidence and severity of post-operative dysphagia.
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
The bags of IV solution will be masked by the pharmacists before sending to the operating room.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing anterior cervical discectomy and fusion for degenerative indications
排除标准
- •history of cervical trauma
- •baseline dysphagia
- •age less than 18 years old
- •history of previous anterior neck surgery
- •Creatinine clearance less than 30
- •Creatinine greater than 1.0
- •baseline sodium greater than 145
- •patients with known electrolyte abnormalities
- •congestive heart failure
研究组 & 干预措施
3% sodium chloride
Subjects in this group will receive 3% sodium chloride over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.
干预措施: 3% Sodium Chloride (Drug)
Normal Saline
This group will receive normal saline over a period of 24 hours at a rate of 10 cc/hour beginning immediately prior to incision.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Post-operative dysphagia
时间窗: Change in dysphagia scores will be assessed from pre-operative baseline value to: post-operative day one value, 2 week value, 6 week value, and 12 week value.
Dysphagia as assessed by the Bazaz Dysphagia Score. The Bazaz score grades dysphagia based on a short questionnaire as "none", "mild", "moderate", and "severe".
次要结局
未报告次要终点