Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline

NCT02416934 | Completed Results DMC

• 1 other identifier: 1405296745
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Swallowing Difficulty

  Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.

  1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.

• Fusion Rate Steroid vs Placebo

  1 year

Study Arms (2)

Treatment 1; Dexamethasone

EXPERIMENTAL

Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.

Drug: Treatment 1; Dexamethasone

Treatment 0; Saline placebo

PLACEBO COMPARATOR

Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery. Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses.

Drug: Treatment 0; Saline placebo

Interventions

Treatment 1; Dexamethasone DRUG

Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.

Also known as: Steroid

Treatment 1; Dexamethasone

Treatment 0; Saline placebo DRUG

Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.

Also known as: Saline

Treatment 0; Saline placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective anterior approach to subaxial cervical spine (C3 - T1);
• ages 18-80

You may not qualify if:

• Traumatic or tumor etiologies
• undergoing anterior-posterior operations
• neoplastic, or infectious conditions requiring surgery
• a history of previous anterior cervical spine surgery
• any patient requiring a halo vest
• patients on chronic steroids
• patients remaining intubated post-operatively (please see more under risks below)
• less than 18 years of age
• pregnant women
• no phone

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (13)

• Riley LH 3rd, Vaccaro AR, Dettori JR, Hashimoto R. Postoperative dysphagia in anterior cervical spine surgery. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S76-85. doi: 10.1097/BRS.0b013e3181d81a96.

  PMID: 20407354 BACKGROUND

• Fountas KN. Re: Papavero L, Heese O, Klotz-Regener V, et al. The impact of esophagus retraction on early dysphagia after anterior cervical surgery. Spine 2007;32:1089-93. Spine (Phila Pa 1976). 2007 Dec 15;32(26):3090. doi: 10.1097/BRS.0b013e31815cd40f. No abstract available.

  PMID: 18091507 BACKGROUND

• Mendoza-Lattes S, Clifford K, Bartelt R, Stewart J, Clark CR, Boezaart AP. Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am. 2008 Feb;90(2):256-63. doi: 10.2106/JBJS.G.00258.

  PMID: 18245583 BACKGROUND

• Cavusoglu H, Tuncer C, Tanik C, Mutlu Z, Zengin E, Karabagli M, Aydin Y. The impact of automatic retractors on the esophagus during anterior cervical surgery: an experimental in vivo study in a sheep model. J Neurosurg Spine. 2009 Nov;11(5):547-54. doi: 10.3171/2009.6.SPINE09216.

  PMID: 19929356 BACKGROUND

• 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: 17321961 BACKGROUND

• Rihn JA, Kane J, Albert TJ, Vaccaro AR, Hilibrand AS. What is the incidence and severity of dysphagia after anterior cervical surgery? Clin Orthop Relat Res. 2011 Mar;469(3):658-65. doi: 10.1007/s11999-010-1731-8.

  PMID: 21140251 BACKGROUND

• Siska PA, Ponnappan RK, Hohl JB, Lee JY, Kang JD, Donaldson WF 3rd. Dysphagia after anterior cervical spine surgery: a prospective study using the swallowing-quality of life questionnaire and analysis of patient comorbidities. Spine (Phila Pa 1976). 2011 Aug 1;36(17):1387-91. doi: 10.1097/BRS.0b013e31822340f2.

  PMID: 21785303 BACKGROUND

• Kang SH, Kim DK, Seo KM, Kim KT, Kim YB. Multi-level spinal fusion and postoperative prevertebral thickness increase the risk of dysphagia after anterior cervical spine surgery. J Clin Neurosci. 2011 Oct;18(10):1369-73. doi: 10.1016/j.jocn.2011.02.033. Epub 2011 Jul 27.

  PMID: 21798743 BACKGROUND

• 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: 12435974 BACKGROUND

• Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. doi: 10.1097/01.brs.0000186317.86379.02.

  PMID: 16284596 BACKGROUND

• Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4.

  PMID: 12592551 BACKGROUND

• Emery SE, Akhavan S, Miller P, Furey CG, Yoo JU, Rowbottom JR, Bohlman HH. Steroids and risk factors for airway compromise in multilevel cervical corpectomy patients: a prospective, randomized, double-blind study. Spine (Phila Pa 1976). 2009 Feb 1;34(3):229-32. doi: 10.1097/BRS.0b013e318193a287.

  PMID: 19148042 BACKGROUND

• 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: 22020609 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Dexamethasone; Steroids; Sodium Chloride

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Sanford Emery
• Organization: West Virginia University Department of Orthopaedics

semery@hsc.wvu.edu

304-293-1170

Study Officials

• Sanford E Emery, MD, MBA

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair West Virginia University Department of Orthopaedics

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: April 15, 2015
• Study Start: July 1, 2012
• Primary Completion: May 15, 2016
• Study Completion: May 15, 2017
• Last Updated: February 5, 2019
• Results First Posted: March 30, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one year of study completion
• Access Criteria: Through a published manuscript and to participants via phone call or clinic visit when the participants return for regularly scheduled follow up visits.

Locations

US (1)