NCT02724761

Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Andrew Chung · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dysphagia
• Dysphonia
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Racemic Epinephrine	1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery
DRUG	Placebo (for racemic epinephrine)	0.5 mL of normal saline will be prepared in an identical amber syringe as the drug intervention (racemic epinephrine)

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2016-03-31
• Last updated: 2016-03-31

Locations

1 site across 1 country: United States