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Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion

NCT ID: NCT02724761

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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

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Dysphagia Dysphonia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental: Racemic Epinephrine

Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine

Group Type EXPERIMENTAL

Racemic Epinephrine

Intervention Type DRUG

1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery

Placebo: 0.9% Normal Saline

0.5 mL 0.9% Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo (for racemic epinephrine)

Intervention Type DRUG

0.5 mL of normal saline will be prepared in an identical amber syringe as the drug intervention (racemic epinephrine)

Interventions

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Racemic Epinephrine

1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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AsthmaNefrin 0.9% normal saline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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More Foundation

OTHER

Sponsor Role collaborator

Banner Health

OTHER

Sponsor Role collaborator

Andrew Chung

OTHER

Sponsor Role lead

Responsible Party

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Andrew Chung

Co-Investigator, Resident Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Norman Chutkan, MD

Role: PRINCIPAL_INVESTIGATOR

The CORE Institute, Banner University Medical Center

Locations

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Banner University Medical Center

Phoenix, Arizona, United States

Site Status

Countries

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United States

Central Contacts

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Andrew S Chung, DO

Role: CONTACT

Phone: 4049381687

Email: [email protected]

Chutkan, MD

Role: CONTACT

References

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Kalb S, Reis MT, Cowperthwaite MC, Fox DJ, Lefevre R, Theodore N, Papadopoulos SM, Sonntag VK. Dysphagia after anterior cervical spine surgery: incidence and risk factors. World Neurosurg. 2012 Jan;77(1):183-7. doi: 10.1016/j.wneu.2011.07.004. Epub 2011 Nov 15.

Reference Type BACKGROUND
PMID: 22155226 (View on PubMed)

Jeyamohan SB, Kenning TJ, Petronis KA, Feustel PJ, Drazin D, DiRisio DJ. Effect of steroid use in anterior cervical discectomy and fusion: a randomized controlled trial. J Neurosurg Spine. 2015 Aug;23(2):137-43. doi: 10.3171/2014.12.SPINE14477. Epub 2015 May 1.

Reference Type BACKGROUND
PMID: 25932600 (View on PubMed)

Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. doi: 10.1097/00007632-200211150-00007.

Reference Type BACKGROUND
PMID: 12435974 (View on PubMed)

Singh K, Marquez-Lara A, Nandyala SV, Patel AA, Fineberg SJ. Incidence and risk factors for dysphagia after anterior cervical fusion. Spine (Phila Pa 1976). 2013 Oct 1;38(21):1820-5. doi: 10.1097/BRS.0b013e3182a3dbda.

Reference Type BACKGROUND
PMID: 23873236 (View on PubMed)

Lee MJ, Bazaz R, Furey CG, Yoo J. Risk factors for dysphagia after anterior cervical spine surgery: a two-year prospective cohort study. Spine J. 2007 Mar-Apr;7(2):141-7. doi: 10.1016/j.spinee.2006.02.024. Epub 2007 Jan 22.

Reference Type BACKGROUND
PMID: 17321961 (View on PubMed)

Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0.

Reference Type BACKGROUND
PMID: 22020609 (View on PubMed)

Song KJ, Lee SK, Ko JH, Yoo MJ, Kim DY, Lee KB. The clinical efficacy of short-term steroid treatment in multilevel anterior cervical arthrodesis. Spine J. 2014 Dec 1;14(12):2954-8. doi: 10.1016/j.spinee.2014.06.005. Epub 2014 Jun 12.

Reference Type BACKGROUND
PMID: 24929058 (View on PubMed)

Plint AC, Osmond MH, Klassen TP. The efficacy of nebulized racemic epinephrine in children with acute asthma: a randomized, double-blind trial. Acad Emerg Med. 2000 Oct;7(10):1097-103. doi: 10.1111/j.1553-2712.2000.tb01258.x.

Reference Type BACKGROUND
PMID: 11015240 (View on PubMed)

Langley JM, Smith MB, LeBlanc JC, Joudrey H, Ojah CR, Pianosi P. Racemic epinephrine compared to salbutamol in hospitalized young children with bronchiolitis; a randomized controlled clinical trial [ISRCTN46561076]. BMC Pediatr. 2005 May 5;5(1):7. doi: 10.1186/1471-2431-5-7.

Reference Type BACKGROUND
PMID: 15876347 (View on PubMed)

Other Identifiers

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BannerHealth

Identifier Type: -

Identifier Source: org_study_id