NCT02724761

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

March 7, 2016

Last Update Submit

March 30, 2016

Conditions

DysphagiaDysphoniaPostoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Change in Dysphagia Numeric Rating Scale (DNRS)

    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

    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 Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

Experimental: Racemic Epinephrine

EXPERIMENTAL

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

Drug: Racemic Epinephrine

Placebo: 0.9% Normal Saline

PLACEBO COMPARATOR

0.5 mL 0.9% Normal Saline

Drug: Placebo (for racemic epinephrine)

Interventions

Racemic EpinephrineDRUG

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

Also known as: AsthmaNefrin
Experimental: Racemic Epinephrine
Placebo (for racemic epinephrine)DRUG

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

Also known as: 0.9% normal saline
Placebo: 0.9% Normal Saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years of age
  • Primary two and three-level ACDF between C3-7
  • Approved pre-authorization to undergo the procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Related Publications (9)

  • 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.

    PMID: 22155226BACKGROUND

  • 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.

    PMID: 25932600BACKGROUND

  • 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.

    PMID: 12435974BACKGROUND

  • 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.

    PMID: 23873236BACKGROUND

  • 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.

    PMID: 17321961BACKGROUND

  • 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.

    PMID: 22020609BACKGROUND

  • 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.

    PMID: 24929058BACKGROUND

  • 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.

    PMID: 11015240BACKGROUND

  • 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.

    PMID: 15876347BACKGROUND

MeSH Terms

Conditions

Deglutition DisordersDysphoniaPain, Postoperative

Interventions

RacepinephrineEpinephrineSaline Solution

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiratory Tract DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Norman Chutkan, MD

    The CORE Institute, Banner University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew S Chung, DO

CONTACT

4049381687andrew.chung@bannerhealth.com

Chutkan, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Investigator, Resident Physician

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 31, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

March 31, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)