Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

March 30, 2016 updated by: Andrew Chung

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chutkan, MD

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients > 18 years of age
  2. Primary two and three-level ACDF between C3-7
  3. Approved pre-authorization to undergo the procedure

Exclusion Criteria:

  1. Patients < 18 years of age
  2. Patients who are unable to give their own consent
  3. Revision ACDF
  4. Combined anterior-posterior surgeries
  5. Surgeries involving C2-C3 or C7-T1
  6. Surgeries related to trauma, infection, or tumor
  7. Patients with baseline swallowing dysfunction
  8. Patients currently on steroids
  9. Patients with severe cardiac disease
  10. Uncontrolled diabetics as defined by patients with a HbA1C > 8%
  11. Patients with known allergy to epinephrine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental: Racemic Epinephrine
Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine
Drug: Racemic Epinephrine
1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery
Other Names:
  • AsthmaNefrin
PLACEBO_COMPARATOR: Placebo: 0.9% Normal Saline
0.5 mL 0.9% Normal Saline
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)
Other Names:
  • 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dysphagia Numeric Rating Scale (DNRS)
Time Frame: 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.
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).
Change in Visual Analogue Scale (VAS) - Odynophagia
Time Frame: 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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Rate of dysphonia
Time Frame: 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).
Patients will be asked to answer whether or not they are experiencing dysphonia with a simple "yes" or "no".
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
Time Frame: Up to 1 month post-operatively
Any airway complication related to post-operative swelling that requires intubation will be retrospectively recorded off of hospital records. This will be recorded as the number of patients requiring intubation. This number will be reported in any future presentation of data.
Up to 1 month post-operatively
Length of Stay
Time Frame: Up to 30 days post-operatively.
Length of hospital stay following surgery
Up to 30 days post-operatively.
Hospital Cost
Time Frame: Up to 30 days post-operatively.
Will determine any additional cost of care associated with dysphagia, dysphonia, airway complications. This will include any emergency department visits or hospital re-admissions directly related to these post-operative complications.
Up to 30 days post-operatively.
30-day Hospital re-admission rates
Time Frame: Up to 30 days post-operatively.
any re-admission in the first 30 days following surgery specifically due to dysphagia, dysphonia, or airway complications related to surgery.
Up to 30 days post-operatively.
Number of emergency department visits per patient related to surgical complications of dysphagia or difficulty breathing
Time Frame: 30 days
Number of emergency department visits in the first 30 days following surgery with patient complaint of "difficulty or pain with swallowing" or "difficulty breathing" as direct complications of surgery (i.e. secondary to post-operative swelling, hematoma formation). Patient charts will be retrospectively reviewed 30 days post-operatively.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrew Chung

Collaborators

More Foundation
Banner Health

Investigators

  • Principal Investigator: Norman Chutkan, MD, The CORE Institute, Banner University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BannerHealth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be be presented in a research paper format and submitted to a journal following completion of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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