Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- Andrew Chung
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Dysphagia Numeric Rating Scale (DNRS)
研究概览
简要总结
Our double-blinded, randomized control trial will assess the effect of nebulized racemic epinephrine inpatients undergoing anterior cervical discectomy and fusion (ACDF) procedures. The investigators have had success in managing post-operative dysphagia in patients undergoing ACDF with the administration of this drug. Half of the participants will review nebulized epinephrine. The other half will receive placebo.
详细描述
Based on data from the National Inpatient Sample from 2002-2012, patients undergoing elective primary ACDF, diagnosed with dysphagia (4% of total patients), had a two-fold increase in mean length of stay (4.03 compared to 1.56 days; p < 0.001) and a substantial increase in their total hospital charges (p < 0.001) versus those not diagnosed with dysphagia. There are very few level I studies which describe successful management of these complications. Steroids have shown promise, however, there exist concerns for consequent delayed bony fusion. Racemic epinephrine is a mixture of both the R and L isomers of epinephrine which theoretically results in a milder side effect profile and longer shelf-life versus the standard L-epinephrine. Traditionally, racemic epinephrine has been administered in a nebulized form for the treatment of severe asthma, laryngeal edema, and bronchiolitis. The most severe side effects that have been reported include tachyarrhythmias and paradoxical bronchospasms, although these reports are rare and limited mainly to single case reports or case series. It confers its therapeutic effect through Racemic α-adrenergic and β-adrenergic mediated vasoconstriction of mucosal vasculature decreasing edema and in the respiratory tract, inducing bronchodilation. The PI, has been utilizing nebulized racemic epinephrine at standard dosages (1 unit of 0.5 ml of 2.25% racemic epinephrine) for the treatment of severe post-operative dysphagia in patients undergoing ACDF for 20 years. The investigator has achieved marked success with this intervention with no notable associated complications. Despite being successfully utilized in this manner for many years in small pockets of the spine community, the use of prophylactic racemic epinephrine for the management of dysphagia has not been described in the literature. The investigators hope to be able to fill this important knowledge-gap with our study data.
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
- 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
- 是
入选标准
- •Patients > 18 years of age
- •Primary two and three-level ACDF between C3-7
- •Approved pre-authorization to undergo the procedure
排除标准
- •Patients < 18 years of age
- •Patients who are unable to give their own consent
- •Revision ACDF
- •Combined anterior-posterior surgeries
- •Surgeries involving C2-C3 or C7-T1
- •Surgeries related to trauma, infection, or tumor
- •Patients with baseline swallowing dysfunction
- •Patients currently on steroids
- •Patients with severe cardiac disease
- •Uncontrolled diabetics as defined by patients with a HbA1C > 8%
- •Patients with known allergy to epinephrine
研究组 & 干预措施
Experimental: Racemic Epinephrine
Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine
干预措施: Racemic Epinephrine (Drug)
Placebo: 0.9% Normal Saline
0.5 mL 0.9% Normal Saline
干预措施: Placebo (for racemic epinephrine) (Drug)
结局指标
主要结局
Change in Dysphagia Numeric Rating Scale (DNRS)
时间窗: Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).
It is a simple questionnaire that is a functional assessment of dysphagia i.e. difficulty swallowing solids, liquids, etc. Additionally, asks a simple "yes" and "no" question for the presence of dysphagia.
Change in Visual Analogue Scale (VAS) - Odynophagia
时间窗: Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).
It is a simple self-reported pain intensity scale from 0-10 with 0 being no pain, and 10 being the worst pain possible as it relates to swallowing.
次要结局
- Change in Rate of dysphonia(Post-operative day 1, just prior to hospital discharge (up to 1 week post-operatively), the first post-operative visit (10-14 days post-operatively, up to 30 days from surgery depending on clinical course).)
- Airway complication(Up to 1 month post-operatively)
- Length of Stay(Up to 30 days post-operatively.)
- Hospital Cost(Up to 30 days post-operatively.)
- 30-day Hospital re-admission rates(Up to 30 days post-operatively.)
- Number of emergency department visits per patient related to surgical complications of dysphagia or difficulty breathing(30 days)
研究者
Andrew Chung
Co-Investigator, Resident Physician
Banner Health