DysphagiaNCT02724761
Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion
A study testing Racemic Epinephrine in people with Dysphagia and Dysphonia, run by Andrew Chung at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Dysphonia, Postoperative Pain
- What is being tested?
- Racemic Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Primary two and three-level ACDF between C3-7
- Approved pre-authorization to undergo the procedure
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Chutkan, MD contact
United States1 site
Banner University Medical Center
Phoenix, Arizona, 85006
About this study
Official title: 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.
Read the 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
- Being tested
- Racemic Epinephrine, Placebo (for racemic epinephrine)
- Medical subject headings
- Deglutition Disorders, Dysphonia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Racemic EpinephrineDrug
Also called AsthmaNefrin
1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery
Placebo (for racemic epinephrine)Drug
Also called 0.9% normal saline
0.5 mL of normal saline will be prepared in an identical amber syringe as the drug intervention (racemic epinephrine)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Racemic Epinephrine | Experimental | Over the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine Receives: Drug: Racemic Epinephrine |
| Placebo: 0.9% Normal Saline | Placebo comparator | 0.5 mL 0.9% Normal Saline Receives: Drug: Placebo (for racemic epinephrine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Patients will be asked to answer whether or not they are experiencing dysphonia with a simple "yes" or "no".
Measured: 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
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.
Measured: Up to 1 month post-operatively
Length of Stay
Length of hospital stay following surgery
Measured: Up to 30 days post-operatively.
Hospital Cost
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.
Measured: Up to 30 days post-operatively.
30-day Hospital re-admission rates
any re-admission in the first 30 days following surgery specifically due to dysphagia, dysphonia, or airway complications related to surgery.
Measured: Up to 30 days post-operatively.
Number of emergency department visits per patient related to surgical complications of dysphagia or difficulty breathing
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrew Chung
- Sponsor type
- University, hospital or other
- Collaborators
- More Foundation, Banner Health
- Responsible party
- Sponsor-investigator, Andrew Chung, Banner Health
- Investigators
- Norman Chutkan, MD, Principal investigator, The CORE Institute, Banner University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724761
- Sponsor's protocol ID
- BannerHealth
- Status last verified
- Mar 2016
- First submitted
- 7 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be be presented in a research paper format and submitted to a journal following completion of the study.
Publications
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.
PubMed 22155226Jeyamohan 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.
PubMed 25932600Bazaz 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.
PubMed 12435974Singh 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.
PubMed 23873236Lee 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.
PubMed 17321961Lee 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.
PubMed 22020609Song 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.
PubMed 24929058Plint 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.
PubMed 11015240Langley 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.
PubMed 15876347
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Racemic Epinephrine for the Prevention of Dysphagia in Patients Undergoing Anterior Cervical Discectomy and Fusion: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02724761
- Acronym / sponsor ID
- BannerHealth
- Conditions
- Dysphagia, Dysphonia, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Andrew ChungUniversity, hospital or other
- Collaborators
- More Foundation, Banner Health
- Study start
- Sep 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Racemic Epinephrine | Experimental | Drug: Racemic EpinephrineOver the Counter (OTC) - 0.5 mL Nebulized Racemic Epinephrine |
| Placebo: 0.9% Normal Saline | Placebo comparator | Drug: Placebo (for racemic epinephrine)0.5 mL 0.9% Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Primary two and three-level ACDF between C3-7
- Approved pre-authorization to undergo the procedure
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Racemic EpinephrineAlso: AsthmaNefrin1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery | Drug | Experimental: Racemic Epinephrine |
| Placebo (for racemic epinephrine)Also: 0.9% normal saline0.5 mL of normal saline will be prepared in an identical amber syringe as the drug intervention (racemic epinephrine) | Drug | Placebo: 0.9% Normal Saline |
Primary outcome
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.
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.
6 secondary outcomes
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).
Airway complication
Time frame: Up to 1 month post-operatively
Length of Stay
Time frame: Up to 30 days post-operatively.
Hospital Cost
Time frame: Up to 30 days post-operatively.
30-day Hospital re-admission rates
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Background: PubMed 22155226Kalb 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.
- Background: PubMed 25932600Jeyamohan 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.
- Background: PubMed 12435974Bazaz 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.
- Background: PubMed 23873236Singh 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.
- Background: PubMed 17321961Lee 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.
- Background: PubMed 22020609Lee 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.
- Background: PubMed 24929058Song 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.
- Background: PubMed 11015240Plint 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.
- Background: PubMed 15876347Langley 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.
- Individual participant dataSharing planned: Yes. Data will be be presented in a research paper format and submitted to a journal following completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chutkan, MD contact
Norman Chutkan, MD principal investigator
The CORE Institute, Banner University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Racemic Epinephrine in people with Dysphagia and Dysphonia, run by Andrew Chung at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew S Chung, DO (4049381687, andrew.chung@bannerhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724761, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.